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Drug Recalls

Last updated

Every drug recall in FDA enforcement reports from the last three years, plus older recalls that are still open. Filter by severity, status or medicine, and check the lot numbers on your package.

0 Class I (most serious) drug recalls reported in the last 30 days.

3,228 recalls

  • Class II Ongoing

    SEMAGLUTIDE 3 MG/ML INJECTABLE, 8 x 0.1 mL syringes, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936

    Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

    Carolina Infusion, LLC · Semaglutide

    Lots, distribution and details
    Lots / codes
    Lot: 08262026@6, BUD:10/10/2026.
    Distribution
    Nationwide within the U.S
    Quantity
    8 x 0.1 ml syringes
    Recall started
    September 10, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0018-2027
  • Class II Ongoing

    TIRZEPATIDE 26 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936;

    Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

    Carolina Infusion, LLC · Tirzepatide

    Lots, distribution and details
    Lots / codes
    Lots: 09012026@3, BUD: 10/16/2026; 08032026@16, BUD: 9/17/2026; 08052026@8, BUD: 9/19/2026; 08072026@13, BUD: 9/21/2026.
    Distribution
    Nationwide within the U.S
    Quantity
    5.6 mLs – in patient specific syringe doses
    Recall started
    September 10, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0017-2027
  • Class II Ongoing

    IMAAVY (nipocalimab-aahu) Injection, 300 mg /1.62 mL (185 mg/mL) per single-dose vial, For Intravenous Infusion After Dilution, Rx only, Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044. NDC: 57894-800-01

    Reason: Presence of particulate matter.

    J&J INNOVATIVE MEDICINE · Nipocalimab

    Lots, distribution and details
    Product
    IMAAVY (nipocalimab-aahu) Injection, 300 mg /1.62 mL (185 mg/mL) per single-dose vial, For Intravenous Infusion After Dilution, Rx only, Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044. NDC: 57894-800-01
    Lots / codes
    Lot JNYJ1208; Exp. 10/30/2027
    Distribution
    OH
    Quantity
    49 vials
    Recall started
    September 23, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0016-2027
  • Class II Ongoing

    Fosfomycin Tromethamine Granules for Oral Solution, (Equivalent to 3 Grams of Fosfomycin), 1 Single-Dose Sachet, Rx only, Manufactured by: Cipla Ltd., Kurkumbh-413802, Maharashtra, India, Manufactured for: Cipla USA, Inc…

    Reason: Failed Impurities/Degradation Specifications

    Cipla USA, Inc. · Fosfomycin Tromethamine

    Lots, distribution and details
    Product
    Fosfomycin Tromethamine Granules for Oral Solution, (Equivalent to 3 Grams of Fosfomycin), 1 Single-Dose Sachet, Rx only, Manufactured by: Cipla Ltd., Kurkumbh-413802, Maharashtra, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-579-67.
    Lots / codes
    Lot#: 5KA0405, Exp 12/31/2026.
    Distribution
    USA Nationwide.
    Quantity
    N/A
    Recall started
    September 18, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0014-2027
  • Class II Ongoing

    Lidocaine Ointment USP, 5% (Generic for Xylocaine), packaged in a 50 g jar, Rx only, Mfg: Taro Pharmaceuticals U.S.A., Inc., Prod# (NDC): 68788-7865-05

    Reason: Failed Content Uniformity Specifications

    Preferred Pharmaceuticals, Inc. · Lidocaine

    Lots, distribution and details
    Lots / codes
    Lot #: F1925G, Expiry: 4/30/2027; Lot #: E0925T, Expiry: 4/30/2027; Lot # D3025M, Expiry: 4/30/2027; Lot #: D0825D, Expiry: 4/30/2027.
    Distribution
    USA Nationwide
    Quantity
    N/A
    Recall started
    September 28, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0013-2027
  • Class II Ongoing

    Biospectra Tris/Tromethamine, USP, GMP, API Grade, Manufactured at 100 Majestic Way, Bangor, PA 18013, NDC 64173-101-25

    Reason: Failed stability specifications

    BioSpectra, Inc.

    Lots, distribution and details
    Lots / codes
    Lot#: TRIS -E04-0226-0016; Exp 2/29/28
    Distribution
    CA
    Quantity
    200 kg
    Recall started
    July 29, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0012-2027
  • Class II Ongoing

    Sterile High Performance Ultra Lubricating Eye Drops (Polyethylene Glycol 400, 0.4% Relieves Dry and Irritated Eyes) Product size: 0.5 fl oz (15 mL); a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myl…

    Reason: Lack of Assurance of Sterility

    K.C. Pharmaceuticals, Inc.

    Lots, distribution and details
    Product
    Sterile High Performance Ultra Lubricating Eye Drops (Polyethylene Glycol 400, 0.4% Relieves Dry and Irritated Eyes) Product size: 0.5 fl oz (15 mL); a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0457-1; b) exchange select, Manufactured for your Military Exchange By: K.C Pharmaceuticals, Inc., Pomona, CA 9176, UPC: 6 1429905619 0; c) Good Sense, Distributed By: Perrigo Direct Inc., Peachtree City, GA 30269, NDC 50804-160-01; d) Walgreens, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD, DEERFIELD, IL 60015, UPC 3 11917 20167 2.
    Lots / codes
    Lot: a) SU25B01, Exp.: 02/28/2027; b) SU25N01, Exp.: 11/30/2027; c) SU25B01, Exp.: 02/28/2027; SU25N01, Exp.: 11/30/2027; SU25N02, Exp.: 11/30/2027; d) SU25B01, Exp.: 02/28/2027.
    Distribution
    US Nationwide
    Quantity
    163,008 cartons
    Recall started
    September 11, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0009-2027
  • Class II Ongoing

    Sterile Eye Drops Redness Relief (Glycerin 0.25%, Naphazoline HCl 0.02% Lubricant | Redness Reliever) (Relieves Dryness, Burning and Irritations), 0.5 fl oz (15 mL); a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHI…

    Reason: Lack of Assurance of Sterility

    K.C. Pharmaceuticals, Inc.

    Lots, distribution and details
    Product
    Sterile Eye Drops Redness Relief (Glycerin 0.25%, Naphazoline HCl 0.02% Lubricant | Redness Reliever) (Relieves Dryness, Burning and Irritations), 0.5 fl oz (15 mL); a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0010-1; b) Discount drug mart, Distributed by: Discount Drug Mart, 211 Commerce Drive, Medina, OH 44256, UPC: 0 93351 03411 4; c) EQUALINE, DISTRIBUTED BY: UNFI, PROVIDENCE, RI 02908 UPC 0 41163 46151 2; d) Colirio Ojo de Aguila, Distributed by Grandall Distributing Co., Inc., Glendale, CA 91204, UPC: 3 48201 01615 5; e) Clear Eyes Redness Relief, ¿ 2025 Dist. by Medtech Products Inc., Tarrytown, NY 10591, UPC 6 78112 25415 6; f) Equate", DISTRIBUTED BY WALMART INC., Bentonville, AR 72716, NDC 79903-012-01; g) Walgreens, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD, DEERFIELD, IL 60015, UPC 3 11917 17741 0; h) Xpect Industrial Eye Relief, Distributed by: Cintas Corp., Mason, OH 45040, UPC: 130209.
    Lots / codes
    Lot: a) RL25D01, Exp.: 04/30/2027; RL25G01, Exp.: 07/31/2027; RL25K05, Exp.: 09/30/2027; RL25N03, Exp.: 11/30/2027; b) RL25D01, Exp.: 04/30/2027; RL25G01, Exp.: 07/31/2027; c) RL25D01, Exp.: 04/30/2027; d) RL25E01, Exp.: 05/31/2027; RL25K05, Exp.: 09/30/2027; e) RL25G02, Exp.: 07/31/2027; RL25G03, Exp.: 07/31/2027; RL25G04, Exp.: 07/31/2027; RL25H02, Exp.: 08/30/2028; RL25H03, Exp.: 08/30/2028; RL25H04, Exp.: 08/30/2028; RL25K01, Exp.: 09/30/2027; RL25K02, Exp.: 09/30/2027; RL25K03, Exp.: 09/30/2027; RL25K04, Exp.: 09/30/2027; RL25M01, Exp.: 10/31/2027; RL25M02, Exp.: 10/31/2027; RL25M03, Exp.: 10/31/2027; RL25M04, Exp.: 10/31/2027; RL25N01, Exp.: 11/30/2027; RL25N02, Exp.: 11/30/2027; RL25N04, Exp.: 11/30/2027; f) RL25E01, Exp.: 05/31/2027; RL25G01, Exp.: 07/31/2027; RL25H01, Exp.: 08/30/2028; RL25K05, Exp.: 09/30/2027; RL25M05, Exp.: 10/31/2027; RL25N03, Exp.: 11/30/2027; g) RL25D01, Exp.: 04/30/2027; RL25E01, Exp.: 05/31/2027; RL25G01, Exp.: 07/31/2027; RL25H01, Exp.: 08/30/2028; RL25K05, Exp.: 09/30/2027; RL25N03, Exp.: 11/30/2027; h) RL25D01, Exp.: 04/30/2027; RL25E01, Exp.: 05/31/2027; RL25H01, Exp.: 08/30/2028; RL25K05, Exp.: 09/30/2027; RL25M05, Exp.: 10/31/2027; RL25N03, Exp.: 11/30/2027.
    Distribution
    US Nationwide
    Quantity
    N/A
    Recall started
    September 11, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0008-2027
  • Class II Ongoing

    Sterile Eye Drops, ORIGINAL, Tetrahydrozoline HCl 0.05% Redness Reliever ¿ Fast Acting Formula) Product size: 0.5 fl oz (15 mL); a) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS CITY, KS 66106…

    Reason: Lack of Assurance of Sterility

    K.C. Pharmaceuticals, Inc.

    Lots, distribution and details
    Product
    Sterile Eye Drops, ORIGINAL, Tetrahydrozoline HCl 0.05% Redness Reliever ¿ Fast Acting Formula) Product size: 0.5 fl oz (15 mL); a) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS CITY, KS 66106, UPC 0 70038 47011 3; b) Discount drug mart, Discount Drug Mart Food Fair, Medina, OH 44256, UPC: 0 93351 01157 3; c) Good Sense Sterile Eye Drops, Distributed By: Geiss, Destin & Dunn, Inc., A Perrigo Company, Peachtree City, GA 30269, NDC 50804-141-01; d) H.E.B Dry Eye, Eye Drops, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43747 4; e) Harris Teeter, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATTHEWS, NC 28105, UPC: 0 72036 71302 5; f) Circle K, Product manufactured for: Lil' Drug Store Products, Inc., Cedar Rapids, IA 52404, Proudly distributed: by Circle K Stores Inc., UPC: 1 94283 65135 8; g) Lil' DrugStore, Product manufactured for: Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404, UPC: 3 66715 68324 3; h) QC, Quality Choice, Distributed by CDMA Inc, Novi, MI NDC 83324-340-15; i) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 03639 0; j) Equate", DISTRIBUTED BY WALMART INC., Bentonville, AR 72716, NDC 79903-158-05; k) Walgreens, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD, DEERFIELD, IL 60015, UPC 3 11917 20073 6; l) Kroger, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202, UPC 0 11110 38597 0.
    Lots / codes
    Lot: a) RG24N02, Exp.: 11/30/2026; b) RG25K04, Exp.: 09/30/2027; c) RG24N02, Exp.: 11/30/2026; RG25D01, Exp.: 04/30/2027; RG25D02, Exp.: 04/30/2027; RG25K02, Exp.: 09/30/2027; RG25K03, Exp.: 09/30/2027; RG25N02, Exp.: 11/30/2027; d) RG24N02, Exp.: 11/30/2026; e) RG25K04, Exp.: 09/30/2027; f) RG24N02, Exp.: 11/30/2026; RG25D01, Exp.: 04/30/2027; RG25D02, Exp.: 04/30/2027; RG25K03, Exp.: 09/30/2027; RG25K04, Exp.: 09/30/2027; RG25N02, Exp.: 11/30/2027; RG25N03, Exp.: 11/30/2027; g) RG24N02, Exp.: 11/30/2026; RG25D01, Exp.: 04/30/2027; RG25D02, Exp.: 04/30/2027; RG25K02, Exp.: 09/30/2027; RG25K04, Exp.: 09/30/2027; RG25K05, Exp.: 09/30/2027; RG25N02, Exp.: 11/30/2027; h) RG25K05, Exp.: 09/30/2027; i) RG24N02, Exp.: 11/30/2026; RG25K04, Exp.: 09/30/2027; RG25M01, Exp.: 10/31/2027; RG25N02, Exp.: 11/30/2027; RG25N03, Exp.: 11/30/2027; j) RG25E01, Exp.: 05/31/2027; RG25K01, Exp.: 09/30/2027; RG25K02, Exp.: 09/30/2027; RG25K05, Exp.: 09/30/2027; RG25M01, Exp.: 10/31/2027; RG25M02, Exp.: 10/31/2027; RG25P01, Exp.: 12/31/2027; k) RG25D01, Exp.: 04/30/2027; RG25K03, Exp.: 09/30/2027; l) RG24N02, Exp.: 11/30/2026;
    Distribution
    US Nationwide
    Quantity
    1,025,448 cartons
    Recall started
    September 11, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0007-2027
  • Class II Ongoing

    Sterile Lubricant Dry Eye Relief Eye Drops, 0.5 FL OZ (15 mL); a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0502-1; b) Crocodile Tears, Distributed by: Crocodile Tears, Palm…

    Reason: Lack of Assurance of Sterility

    K.C. Pharmaceuticals, Inc.

    Lots, distribution and details
    Product
    Sterile Lubricant Dry Eye Relief Eye Drops, 0.5 FL OZ (15 mL); a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0502-1; b) Crocodile Tears, Distributed by: Crocodile Tears, Palm Beach Gardens, FL 33410, UPC: 8 67166 00000 4; c) Discount drug mart, Discount Drug Mart Food Fair, Medina, OH 44256, UPC: 0 93351 01156 6; d) exchange select, Manufactured for your Military Exchange By: K.C Pharmaceuticals, Inc., Pomona, CA 9176, UPC: 6 14299 05620 6; e) GERI CARE, Distributed by: Gericare Pharmaceuticals Corp., 1295 Towbin Ave., Lakewood, NJ 08701, NDC 57896-181-05; f) H.E.B Dry Eye, Eye Drops, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43741 2; g) Harris Teeter, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATTHEWS, NC 28105, UPC: 0 72036 71303 2; h) Foster & Thrive, Distributed by: McKesson Corp. Via Strategic Sourcing Servies LLC., Memphis, TN 38141, NDC 70677-1157-1; I) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 36100 3.
    Lots / codes
    Lot: a) LT25B01, Exp.: 02/28/2027; b) LT25D02, Exp.: 04/30/2027; LT25K01, Exp.: 09/30/2027; c) LT25D02, Exp.: 04/30/2027; LT25K01, Exp.: 09/30/2027; d) LT25D02, Exp.: 04/30/2027; LT25M02, Exp.: 10/31/2027; e) LT25B01, Exp.: 02/28/2027; LT25D01, Exp.: 04/30/2027; LT25D02, Exp.: 04/30/2027; LT25K01, Exp.: 09/30/2027; LT25M01, Exp.: 10/31/2027; LT25M02, Exp.: 10/31/2027; LT25N01, Exp.: 11/30/2027; LT25N02, Exp.: 11/30/2027; f) LT25B01, Exp.: 02/28/2027; g) LT25M02, Exp.: 10/31/2027; h) LT25B01, Exp.: 02/28/2027; I) LT25B01, Exp.: 02/28/2027; LT25D02, Exp.: 04/30/2027; LT25M02, Exp.: 10/31/2027.
    Distribution
    US Nationwide
    Quantity
    1,327,248 cartons
    Recall started
    September 11, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0006-2027
  • Class II Ongoing

    Eye Drops MAXIMUM, REDNESS RELIEF, Sterile, 1/2 FL OZ (0.5 ML); a) exchange select, Manufactured for your Military Exchange By: K.C Pharmaceuticals, Inc., Pomona, CA 9176, UPC: 6 14299 89636 9; b) Harris Teeter, PROUDLY…

    Reason: Lack of Assurance of Sterility

    K.C. Pharmaceuticals, Inc.

    Lots, distribution and details
    Product
    Eye Drops MAXIMUM, REDNESS RELIEF, Sterile, 1/2 FL OZ (0.5 ML); a) exchange select, Manufactured for your Military Exchange By: K.C Pharmaceuticals, Inc., Pomona, CA 9176, UPC: 6 14299 89636 9; b) Harris Teeter, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATTHEWS, NC 28105, UPC: 0 72036 73589 8; c) TYSON, MIKE RED EYE DROPS, Distributed by: JBRANDS Distribution, Miami, FL 33009, UPC: 7 84847 57549 4; d) up & up, Distributed by: Target Corporation, Minneapolis, MN 55403, NDC 11673-100-01; e) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 21123 0; f) Walgreens, DISTRIBUTED BY: WALGREEN CO. 200 WILMOT RD, DEERFIELD, IL 60015, UPC 3 11917 20075 0.
    Lots / codes
    Lot: a) CM25E02, Exp.: 5/31/2027; CM25M01, Exp.: 10/31/2027; b) CM25E02, Exp.: 5/31/2027; c) CM25C01, Exp.: 3/31/2027; CM25C02, Exp.: 3/31/2027; CM25C03, Exp.: 3/31/2027; CM25E02, Exp.: 5/31/2027; CM25F01, Exp.: 6/30/2027; CM25A02, Exp.: 1/1/2027; CM25B01, Exp.: 2/28/2027; d) CM25B01, Exp.: 2/28/2027; CM25E01, Exp.: 5/31/2027; CM25E02, Exp.: 5/31/2027; CM25K01, Exp.: 9/30/2027; CM25M01, Exp.: 10/31/2027; e) CM25B01, Exp.: 2/28/2027; CM25F01, Exp.: 6/30/2027; CM25K01, Exp.: 9/30/2027; CM25M01, Exp.: 10/31/2027; f) CM25B01, Exp.: 2/28/2027; CM25E02, Exp.: 5/31/2027; CM25K01, Exp.: 9/30/2027; CM25M01, Exp.: 10/31/2027.
    Distribution
    US Nationwide
    Quantity
    1,435,830 cartons
    Recall started
    September 11, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0005-2027
  • Class II Ongoing

    Sterile EYE DROPS Advanced Relief, (dextran 70, 0.1%, polyethylene glycol 400 1% and tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) bottles, Sterile; a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myl…

    Reason: Lack of Assurance of Sterility

    K.C. Pharmaceuticals, Inc.

    Lots, distribution and details
    Product
    Sterile EYE DROPS Advanced Relief, (dextran 70, 0.1%, polyethylene glycol 400 1% and tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) bottles, Sterile; a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0456-1; b) Equaline, DISTRIBUTED BY: UNFI, PROVIDENCE, RI 02908 UPC 0 41163 25392 6; c) GoodSense, Distributed By: Geiss, Destin& Dunn, Inc., A Perrigo Company, Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-130-01; d) H.E.B A.C. Eye Drops, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43745 0; e) Medic'c Choice, Manufactured by KC Pharmaceuticals, Inc., Pomona, CA 91768, NDC 55651-025-01; f) Foster & Thrive, Distributed by: McKesson Corp., via Strategic Sourcing Services LLC, Memphis, TN 38141, NDC 70677-1158-1; g) Colirio Manzanill A+, Distributed by: PRO-MEX, P.O Box 63-0716, Miami , FL 33163, UPC: 1 84125 00018 0; h) P, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, 3300 PUBLIX CORPORATE PARKWAY, LAKELAND, FL 33811, UPC 0 41415 06776 9; I) QC-Quality Choice, Distributed by: CDMA, Inc., Novi, MI 48375, NDC 83324-191-14; J) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 03641 3.
    Lots / codes
    Lot: a) AR25A02, Exp.: 1/1/2027; b) AR25A02, Exp.: 1/1/2027; c) AR25A01, Exp.: 1/1/2027; AR25N01, Exp.: 11/30/2027; d) AR25A02, Exp.: 1/1/2027; e) AR25A02, Exp.: 1/1/2027; f) AR25A02, Exp.: 1/1/2027; g) AR25F01, Exp.: 6/30/2027; AR25N01, Exp.: 11/30/2027; h) AR25A02, Exp.: 1/1/2027; I) AR25A01, Exp.: 1/1/2027; AR25N01, Exp.: 11/30/2027; J) AR25A01, Exp.: 1/1/2027.
    Distribution
    US Nationwide
    Quantity
    208,896 cartons
    Recall started
    September 11, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0004-2027
  • Class II Ongoing

    Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL) bottles; a) Equaline, DISTRIBUTED BY: UNFI, PROVIDENCE, RI 02908 UPC 0 41163 25114 4; b) Good Sense Sterile Eye Drops, Distribute…

    Reason: Lack of Assurance of Sterility

    K.C. Pharmaceuticals, Inc.

    Lots, distribution and details
    Product
    Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL) bottles; a) Equaline, DISTRIBUTED BY: UNFI, PROVIDENCE, RI 02908 UPC 0 41163 25114 4; b) Good Sense Sterile Eye Drops, Distributed By: Geiss, Destin & Dunn, Inc., A Perrigo Company, Peachtree City, GA 30269, NDC 50804-121-01; c) H.E.B A.C. Eye Drops, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43746 7; d) QC-Quality Choice, Sterile Eye drops Irritation Relief, Distributed by: CDMA, Inc., Novi, MI 48375, NDC 83324-190-14; e) TopCare health TM, DISTRIBUTED BY: TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007, UPC 0 36800 03640 6.
    Lots / codes
    Lot: a) AC25C01, Exp.: 3/31/2027; b) AC25B01, Exp.: 2/28/2027; AC25C01, Exp.: 3/31/2027; c) AC25C01, Exp.: 3/31/2027; d) AC25C01, Exp.: 3/31/2027; e) AC25C01, Exp.: 3/31/2027.
    Distribution
    US Nationwide
    Quantity
    182,016 cartons
    Recall started
    September 11, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0003-2027
  • Class II Ongoing

    Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles; a) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS CITY, KS 66106, UPC 0 70038 47…

    Reason: Lack of Assurance of Sterility

    K.C. Pharmaceuticals, Inc.

    Lots, distribution and details
    Product
    Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles; a) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS CITY, KS 66106, UPC 0 70038 47008 3; b) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0011-1; c) Good Neighbor Pharmacy, Distributed By AmerisourceBergen, 1 West First Avenue, Conshohocken, PA 19428, NDC 24385-006-05; d) Good Sense, Distributed By: Geiss, Destin& Dunn, Inc., A Perrigo Company, Peachtree City, GA 30269, NDC 50804-110-01; e) Medic'c Choice, Sterile 0.5 fl. oz. (15 mL), Manufactured by KC Pharmaceuticals, Inc., Pomona, CA 91768, NDC 55651-008-01; f) P, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, LAKELAND, FL 33811, UPC 0 41415 00976 9; g) Quality Choice, Distributed by CDMA Inc, Novi, MI NDC 83324-189-14; h) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 09331 7; I) Walgreens, DISTRIBUTED BY: WALGREEN CO. DEERFIELD, IL 60015, UPC 3 11917 06503 8; J) Kroger, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202, UPC 0 11110 38600 7.
    Lots / codes
    Lot: a) AT25B01, Exp.: 2/28/2027; b) AT24N01, Exp.: 11/30/2026; AT25B01, Exp.: 2/28/2027; AT25D01, Exp.: 04/30/27; AT25F01, Exp.: 6/30/2027; AT25F02, Exp.: 6/30/2027; AT25K02, Exp.: 9/30/2027; c) AT25D01, Exp.: 04/30/27; AT25K02, Exp.: 9/30/2027; d) AT24N01, Exp.: 11/30/2026; AT25B01, Exp.: 2/28/2027; AT25D01, Exp.: 04/30/27; AT25F01, Exp.: 6/30/2027; AT25F02, Exp.: 6/30/2027; AT25K01, Exp.: 9/30/2027; AT25K02, Exp.: 9/30/2027; e) AT25B01, Exp.: 2/28/2027; f) AT25B01, Exp.: 2/28/2027; AT25D01, Exp.: 04/30/27; g) AT25B01, Exp.: 2/28/2027; AT25F02, Exp.: 6/30/2027; AT25K01, Exp.: 9/30/2027; h) AT25B01, Exp.: 2/28/2027; AT25D01, Exp.: 04/30/27; I) AT25D01, Exp.: 04/30/27; AT25F01, Exp.: 6/30/2027; AT25K02, Exp.: 9/30/2027; J) AT24N01, Exp.: 11/30/2026.
    Distribution
    US Nationwide
    Quantity
    505,896 cartons
    Recall started
    September 11, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0002-2027
  • Class II Ongoing

    Benzoyl Peroxide Wash, USP, 10%, packaged in a)5 FL OZ (148mL) bottles (NDC 0536-1261-63), and b) 8.5 FL OZ (237 mL) bottles (NDC 0536-1351-42), Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233,…

    Reason: Microbial contamination of topical product.

    SV Labs Toronto Corporation

    Lots, distribution and details
    Product
    Benzoyl Peroxide Wash, USP, 10%, packaged in a)5 FL OZ (148mL) bottles (NDC 0536-1261-63), and b) 8.5 FL OZ (237 mL) bottles (NDC 0536-1351-42), Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152.
    Lots / codes
    a) Lot #: 0575-01-366, Exp. Date Jan-27; 0565-02-336, Exp. Date FEB-27; b) Lot #: 0645-02-355, 0575-02-336, Exp. Date Feb-27; 0565-12-317, Exp. Date Dec-26
    Distribution
    IL only
    Quantity
    —
    Recall started
    September 1, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0879-2026
  • Class II Ongoing

    Benzoyl Peroxide Wash, USP, 5%, 5 FL OZ (148 mL), Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1259-63

    Reason: Microbial contamination of topical product.

    SV Labs Toronto Corporation

    Lots, distribution and details
    Product
    Benzoyl Peroxide Wash, USP, 5%, 5 FL OZ (148 mL), Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1259-63
    Lots / codes
    Lot #: 0525-02-345, Exp. Date 02/2027
    Distribution
    IL only
    Quantity
    —
    Recall started
    September 1, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0878-2026
  • Class II Ongoing

    Paroxetine Extended-Release Tablets, 37.5mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-1318-3

    Reason: Failed dissolution specifications.

    Apotex Corp. · Paroxetine Hydrochloride

    Lots, distribution and details
    Lots / codes
    Lot# TY9495, Exp Date: 05/2027.
    Distribution
    US Nationwide.
    Quantity
    —
    Recall started
    September 23, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0877-2026
  • Class II Ongoing

    Buprenorphine Hydrochloride, Injection 0.3 mg/mL, Rx Only, 5 x 1 mL Single Dose Vials, Manufactured for: Endo USA, Malvern, PA, NDC 42023-179-05

    Reason: Crystallization

    Par Health USA, LLC · Buprenorphine Hydrochloride

    Lots, distribution and details
    Lots / codes
    Lot#:83912, Exp Date 10/2026 Lot#:84234, Exp Date 11/2026 Lot#:84990, Exp Date 11/2026 Lot#:85003, Exp Date 12/2026 Lot#:86443, Exp Date 01/2027 Lot#:89909, Exp Date 05/2027
    Distribution
    U.S. Nationwide
    Quantity
    154210 bottles
    Recall started
    September 8, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0876-2026
  • Class II Ongoing

    Zoladex (goserelin) implant, 3.6 mg, One single-Use Syringe packaged in a carton, Rx only, Manufactured for: TerSera therapeutics LLC, Deerfield, IL 60015, BY: AstraZeneca UK Limited, Macclesfield, England, Product of Sw…

    Reason: Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient outdoor conditions for 25.5 hours.

    TerSera Therapeutics LLC · Goserelin

    Lots, distribution and details
    Product
    Zoladex (goserelin) implant, 3.6 mg, One single-Use Syringe packaged in a carton, Rx only, Manufactured for: TerSera therapeutics LLC, Deerfield, IL 60015, BY: AstraZeneca UK Limited, Macclesfield, England, Product of Switzerland, website at www.zoladex.com, NDC 70720-950-36.
    Lots / codes
    Lot#: YN0099, Exp 01/31/2028
    Distribution
    USA Nationwide
    Quantity
    296 cartons
    Recall started
    August 31, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0875-2026
  • Class II Ongoing

    FOCUS PI Hypromellose 0.7% Formula, 0.3 FL O (10 mL) per vial, STERILE, Manufactured for: Covalent Management, Inc., Manassas, VA 20109. NDC: 82724-007-19

    Reason: Lack of Assurance of Sterility

    Aurolab Trust

    Lots, distribution and details
    Product
    FOCUS PI Hypromellose 0.7% Formula, 0.3 FL O (10 mL) per vial, STERILE, Manufactured for: Covalent Management, Inc., Manassas, VA 20109. NDC: 82724-007-19
    Lots / codes
    Batch# 6B093FI, Exp. 04/01/28; Batch# 6F511F1, Exp. 05/15/28
    Distribution
    VA
    Quantity
    25,220 bottles
    Recall started
    September 17, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0874-2026
  • Class II Ongoing

    Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08907, NDC 69238-2452-3.

    Reason: Defective Container; packets were found to be either empty or partially full.

    Amneal Pharmaceuticals, LLC · Estradiol Transdermal

    Lots, distribution and details
    Lots / codes
    Lot # 245226005B, Exp Date: 04/30/2028.
    Distribution
    Nationwide in the USA.
    Quantity
    2,592 30-count cartons
    Recall started
    September 8, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0873-2026
  • Class II Ongoing

    Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807. NDC: 27241-126-02

    Reason: Failed Dissolution Specifications: below specification

    Ajanta Pharma USA Inc · Ranolazine

    Lots, distribution and details
    Product
    Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807. NDC: 27241-126-02
    Lots / codes
    Lot: DJ25134, Exp 11/30/2028
    Distribution
    Nationwide in the US.
    Quantity
    —
    Recall started
    September 17, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0010-2027
  • Class II Ongoing

    Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydrochloride 0.012%) with Hang Tag, 0.5 fl oz (15mL) per dropper bottle, STERILE, Dist. by Medtech Products Inc., Tarrytown, N…

    Reason: Lack of Assurance of Sterility

    Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company

    Lots, distribution and details
    Product
    Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydrochloride 0.012%) with Hang Tag, 0.5 fl oz (15mL) per dropper bottle, STERILE, Dist. by Medtech Products Inc., Tarrytown, NY 10591. NDC: 67172-797-15
    Lots / codes
    Lot #: RL25G04, Exp. Date 07/2027; RL2H02, Exp. Date 08/2027.
    Distribution
    Nationwide in the USA.
    Quantity
    —
    Recall started
    September 15, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0871-2026
  • Class II Ongoing

    Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydrochloride 0.012%) , 0.5 fl oz (15mL) per dropper bottle, STERILE, Dist. by Medtech Products Inc., Tarrytown, NY 10591. NDC:…

    Reason: Lack of Assurance of Sterility

    Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company

    Lots, distribution and details
    Product
    Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydrochloride 0.012%) , 0.5 fl oz (15mL) per dropper bottle, STERILE, Dist. by Medtech Products Inc., Tarrytown, NY 10591. NDC: 67172-797-15
    Lots / codes
    Lot #: RL25G02, RL25G03, RL25G04, Exp. Date Jul-27; RL25H02, RL25H03, RL25H04, Exp. Date Aug-27; RL25K01, RL25K02, RL25K03, RL25K04, Exp. Date Sep-27; RL25M01, RL25M02, RL25M03, RL25M04, Exp. Date Oct-27; RL25N01, RL25N02, RL25N04, Exp. Date Nov-27.
    Distribution
    Nationwide in the USA.
    Quantity
    2,356,248 bottles
    Recall started
    September 15, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0870-2026
  • Class II Ongoing

    Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcutaneous Use Only, For Single Patient Use Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213, India; Distributed by: Amn…

    Reason: Defective Delivery System: Possibility of no medication in the prefilled pen.

    Amneal Pharmaceuticals of New York, LLC · Exenatide

    Lots, distribution and details
    Product
    Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcutaneous Use Only, For Single Patient Use Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213, India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 70121-1685-1
    Lots / codes
    Lot #: AP250095A, Exp 2/28/2027
    Distribution
    USA Nationwide
    Quantity
    5,694 pens
    Recall started
    August 28, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0868-2026

Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.

What the recall classes mean

  • Class I Most serious: use could cause serious health problems or death.
  • Class II Could cause temporary or medically reversible health problems; serious harm is unlikely.
  • Class III Not likely to cause health problems — for example a labelling or packaging fault.

Source: FDA Enforcement Report, via openFDA. Updated here twice a day; last update October 31, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.

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