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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.

128 recalls

  • 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

    Fluphenazine HCl Elixir, USP, 20 mg per 4 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04

    Reason: Failed Stability Specifications

    Safecor Health, LLC

    Lots, distribution and details
    Product
    Fluphenazine HCl Elixir, USP, 20 mg per 4 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04
    Lots / codes
    Lot#:25330415; Exp :08/26/2026 Lot#:25340169; Exp :09/05/2026 Lot#:25380387; Exp :10/17/2026 Lot#:25410936; Exp :11/13/2026 Lot#:25450649; Exp :11/30/2026 Lot#:25471328; Exp :01/05/2027 Lot#:26120385; Exp :03/27/2027 Lot#:26141494; Exp :04/07/2027 Lot#:26170183; Exp :04/21/2027 Lot#:26220497; Exp :05/28/2027
    Distribution
    Nationwide in the USA.
    Quantity
    N/A
    Recall started
    August 13, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0846-2026
  • Class II Ongoing

    Fluphenazine HCl Elixir, USP, 15 mg per 3 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04

    Reason: Failed Stability Specifications

    Safecor Health, LLC

    Lots, distribution and details
    Product
    Fluphenazine HCl Elixir, USP, 15 mg per 3 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04
    Lots / codes
    Lot#:26080483; Exp :03/13/2027 Lot#:25310327; Exp :08/12/2026 Lot#:25330414; Exp :08/26/2026 Lot#:25430340; Exp :11/22/2026
    Distribution
    Nationwide in the USA.
    Quantity
    N/A
    Recall started
    August 13, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0845-2026
  • Class II Ongoing

    Fluphenazine HCl Elixir, USP, 10 mg per 2 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04

    Reason: Failed Stability Specifications

    Safecor Health, LLC

    Lots, distribution and details
    Product
    Fluphenazine HCl Elixir, USP, 10 mg per 2 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04
    Lots / codes
    Lot#:25421159; Exp :10/21/2026 Lot#:25431644; Exp :11/03/2026 Lot#:25471687; Exp :12/02/2026 Lot#:25510930; Exp :01/05/2027 Lot#:26130247; Exp :04/17/2027 Lot#:25450648; Exp :11/30/2026 Lot#:26061716; Exp :02/28/2027 Lot#:26120384; Exp :03/27/2027 Lot#:26141493; Exp :04/07/2027 Lot#:26190055; Exp :05/04/2027 Lot#:26231530; Exp :06/05/2027
    Distribution
    Nationwide in the USA.
    Quantity
    N/A
    Recall started
    August 13, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0844-2026
  • Class II Ongoing

    Fluphenazine HCl Elixir, USP, 5 mg per 10 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0654-16

    Reason: Failed Stability Specifications

    Safecor Health, LLC

    Lots, distribution and details
    Product
    Fluphenazine HCl Elixir, USP, 5 mg per 10 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0654-16
    Lots / codes
    Lot#:26220866; Exp :06/18/2027 Lot#:25321477; Exp :0/18/2026 Lot#:25471651; Exp :12/01/2026 Lot#:25500133; Exp :12/19/2026 Lot#:26161398; Exp :12/31/2026 Lot#:26170946; Exp :05/15/2027 Lot#:26240033; Exp :05/31/2027
    Distribution
    Nationwide in the USA.
    Quantity
    N/A
    Recall started
    August 13, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0843-2026
  • Class II Ongoing

    Fluphenazine HCl Elixir, USP, 5 mg per 1 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04

    Reason: Failed Stability Specifications

    Safecor Health, LLC

    Lots, distribution and details
    Product
    Fluphenazine HCl Elixir, USP, 5 mg per 1 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04
    Lots / codes
    Lot #:25330169; Exp :08/25/2026 Lot #:25340107; Exp :09/04/2026 Lot #:25370044; Exp :09/30/2026 Lot #:25391430; Exp :10/30/2026 Lot #:25411035; Exp :11/13/2026 Lot #:25461036; Exp :12/12/2026 Lot #:25450206; Exp :12/12/2026 Lot #:25521269; Exp :02/03/2027 Lot #:26030426; Exp :02/09/2027 Lot #:26071765; Exp :03/11/2027 Lot #:26111371; Exp :03/24/2027 Lot #:26121435; Exp :03/31/2027 Lot #:26141209; Exp :04/07/2027 Lot #:26151211; Exp :04/13/2027 Lot #:26170561; Exp :04/23/2027 Lot #:26171144; Exp :04/24/2027 Lot #:26191168; Exp :05/08/2027 Lot #:26210307; Exp :05/21/2027 Lot #:26231182; Exp :06/04/2027 Lot #:26241285; Exp :06/15/2027
    Distribution
    Nationwide in the USA.
    Quantity
    N/A
    Recall started
    August 13, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0842-2026
  • Class II Ongoing

    Fluphenazine HCl Elixir, USP, 2.5 mg per 5 mL, Delivers: 5 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0654-16

    Reason: Failed Stability Specifications

    Safecor Health, LLC

    Lots, distribution and details
    Product
    Fluphenazine HCl Elixir, USP, 2.5 mg per 5 mL, Delivers: 5 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0654-16
    Lots / codes
    Lot#26160463; Exp :04/20/2027 Lot#25430188; Exp :11/26/2026 Lot#25440715; Exp :12/9/2026 Lot#25501160; Exp :01/21/2027 Lot#26021054; Exp :02/5/2027 Lot#26130635; Exp :04/3/2027 Lot#26200964; Exp :05/13/2027
    Distribution
    Nationwide in the USA.
    Quantity
    N/A
    Recall started
    August 13, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0841-2026
  • Class I Ongoing

    Glutathione 200 mg/mL, 30 mL sterile multidose vial, Each vial contains: Glutathione, Ascorbic Acid, Benzyl Alcohol & sterile water for injection, For IM or IV Injection Use Only, RX only, Optimal Balance Pharmacy, 2204…

    Reason: Microbial Contamination of Sterile Products – out of specifications results were obtained for bacterial endotoxin.

    OPTIMAL BALANCE PHARMACY

    Lots, distribution and details
    Product
    Glutathione 200 mg/mL, 30 mL sterile multidose vial, Each vial contains: Glutathione, Ascorbic Acid, Benzyl Alcohol & sterile water for injection, For IM or IV Injection Use Only, RX only, Optimal Balance Pharmacy, 2204 Cypress Creek Pkwy Suite F, Houston, TX 77090
    Lots / codes
    Lot#: LG342009076, Beyond Use Date: 10/4/26
    Distribution
    USA Nationwide.
    Quantity
    53 vials
    Recall started
    August 5, 2026 (Voluntary: Firm initiated)
    Severity
    Most serious: use could cause serious health problems or death.
    FDA recall number
    D-0851-2026
  • Class I Ongoing

    Glutathione (MDV), 200 mg/mL, 30 mL vial, each mL contains Glutathione 200 mg, Ascorbic Acid 20 mg, Benzyl Alcohol 1.5%, Na Hydroxide (Ph Adjust) in sterile water for injection, VMC.

    Reason: Microbial Contamination of Sterile Products – out of specifications results were obtained for bacterial endotoxin.

    Victory Medical Center Pharmacy

    Lots, distribution and details
    Lots / codes
    Lot # 1984345, 1980571, 1981940, Use Before Date: 08/27/2026.
    Distribution
    USA Nationwide
    Quantity
    91
    Recall started
    July 1, 2026 (Voluntary: Firm initiated)
    Severity
    Most serious: use could cause serious health problems or death.
    FDA recall number
    D-0772-2026
  • Class II Ongoing

    BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL applicators/carton, 0.03fl oz (1 mL) each, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, D…

    Reason: Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator

    CareFusion 213, LLC

    Lots, distribution and details
    Product
    BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL applicators/carton, 0.03fl oz (1 mL) each, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-31
    Lots / codes
    Lots: 4062535, 4065201, 4066446, Exp. 2/28/2027; 4141090, Exp. 5/31/2027; 4180288, 4197695, 4197697, 4180291, Exp. 6/30/2027; 4219454, 4221945, 4221966, 4222853, 4224361, Exp. 7/31/2027; 4228482, 4248656, 4249026, 4248961, 4249818, 4250729, Exp. 8/31/2027; 5124984, 5127231, 5129058, 5126398, 5129488, Exp. 4/30/2028; 5130576, 5142947, 5147432, 5154673, 5154671, 5156442, 5157968, 5158031, 5150160, 5155824, Exp. 5/31/2028; 5176326, 5181676, 5181074, 5182660, 5188102, 5188103, Exp. 6/30/2028; 5195818, 5199118, 5209474, 5210853, 5211985, 5211907, 5211212, Exp. 7/31/2028; 5226576, 5227151, 5230531, 5241733, 5242057, 5243430, 5246952, 5248375, 5248189, Exp. 8/31/2028; 5254509, 5274692, 5276968, 5279226, 5280240, Exp. 9/30/2028; 5305661, 5307185, 5309623, 5310701, Exp. 10/31/2028; 5346128, 5350797, Exp. 12/31/2028; 6031034, 6031234, 6037918, Exp. 1/31/2029; 6051588, 6054213, 6062168, 6063361, Exp. 2/28/2029; 6069891, Exp. 3/31/2029; 6111107, Exp. 4/30/2029.
    Distribution
    U.S.A. Nationwide
    Quantity
    43,066,599 units
    Recall started
    July 9, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0690-2026
  • Class II Ongoing

    Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 32 oz., 946 mL, Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana Llana Rio Piedras, PR 00924, UPC 659685696567.

    Reason: Subpotent drug

    Gasco Industrial Corp.

    Lots, distribution and details
    Lots / codes
    Lots 250206B1, 250218B2, 250507B1, within expiry
    Distribution
    Nationwide within the US
    Quantity
    N/A
    Recall started
    May 29, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0670-2026
  • Class II Ongoing

    Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 16 oz, 474 mL, Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana LLana Rio Piedras, PR 00924, UPC 69685696529

    Reason: Subpotent drug

    Gasco Industrial Corp.

    Lots, distribution and details
    Lots / codes
    Lots 250109B1, 250110B1, 250228B1, 250303B1, 250304B1, 250305B1, 250306B1, 250306B2 within expiry
    Distribution
    Nationwide within the US
    Quantity
    N/A
    Recall started
    May 29, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0669-2026
  • Class II Ongoing

    Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 1 gallon (3.78 liter), Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana LLana Rio Piedras, PR 00924

    Reason: Subpotent drug

    Gasco Industrial Corp.

    Lots, distribution and details
    Lots / codes
    Lots 250221A5, 250224A2 within expiry
    Distribution
    Nationwide within the US
    Quantity
    N/A
    Recall started
    May 29, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0668-2026
  • Class II Ongoing

    Gasco Isopropyl Alcohol 70%, 32 oz (946 mL) Gasco Industrial Corp., PO Box 1360, Gurabo PR 00778, UPC 7 87302 12363 6.

    Reason: Subpotent drug

    Gasco Industrial Corp.

    Lots, distribution and details
    Lots / codes
    Lot 250218B3, within expiry
    Distribution
    Nationwide within the US
    Quantity
    N/A
    Recall started
    May 29, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0667-2026
  • Class II Ongoing

    Gasco Isopropyl Alcohol 70%, Net Contents: 1 US Gallon (3.78 L), Manufactured by: Gasco Industrial Corp., PO Box 1360, Gurabo, PR 00778, Made in USA

    Reason: Subpotent drug

    Gasco Industrial Corp.

    Lots, distribution and details
    Lots / codes
    Lots 250108A2, 250109A1, 250115A1, 250124A1, 250213A1, 250220Z3, 250221A3, 250221A4, 250224A1, 250303A3, 250306A1, 250307A1, within expiry
    Distribution
    Nationwide within the US
    Quantity
    N/A
    Recall started
    May 29, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0666-2026
  • Class II Ongoing

    Gasco Isopropyl Alcohol 70%, Net Contents: 16 Oz. (474 mL). Manufactured by: Gasco Industrial Corp., PO Box 1360 Gurabo PR 00778 Made in USA UPC 7 87302 13044 3

    Reason: Subpotent drug

    Gasco Industrial Corp.

    Lots, distribution and details
    Lots / codes
    Lot 250306B3, within expiry
    Distribution
    Nationwide within the US
    Quantity
    N/A
    Recall started
    May 29, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0665-2026
  • Class II Ongoing

    Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Contains, 1×2 oz bottle Fungal Fusion Antifungal (Miconazole Nitrate) Cream, 1x2oz bottle Fungal Fusion Antifungal Solution (25% Undecylenic Acid) and 1…

    Reason: CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

    Blaine Labs Inc

    Lots, distribution and details
    Product
    Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Contains, 1×2 oz bottle Fungal Fusion Antifungal (Miconazole Nitrate) Cream, 1x2oz bottle Fungal Fusion Antifungal Solution (25% Undecylenic Acid) and 1x1oz bottle of Fungal Fusion Eradication Antimicrobial Show Spray (isopropyl Alcohol, D-Limonene, Undecylenic Acid). Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Santa Fe Springs, CA 90670, Manufactured for Doctor's Inc
    Lots / codes
    Lot BL3572, Exp 04/16/2028
    Distribution
    Nationwide in the USA
    Quantity
    1,500 bottles
    Recall started
    April 8, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0698-2026
  • Class II Ongoing

    BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 100 x 10.5 mL Applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 543…

    Reason: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

    CareFusion 213, LLC

    Lots, distribution and details
    Product
    BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 100 x 10.5 mL Applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-34, catalog number 930700NS.
    Lots / codes
    Lot: 4190081, Exp 06/30/2027
    Distribution
    Distributed Nationwide in the USA
    Quantity
    100 units
    Recall started
    June 11, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0652-2026
  • Class II Ongoing

    BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol),500 x 1 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-…

    Reason: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

    CareFusion 213, LLC

    Lots, distribution and details
    Product
    BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol),500 x 1 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-31, bulk catalog number 930480NSB
    Lots / codes
    Lot: 4088933, Exp 03/31/2027, 4177711, 4195438, Exp 06/30/2027, 5051114, Exp 02/29/2028, 5070540, Exp 03/31/2028, 5106254, Exp 04/30/2028, 5141607, Exp 05/31/2028, 5196494, Exp 07/31/2028.
    Distribution
    Distributed Nationwide in the USA
    Quantity
    18,000 units
    Recall started
    June 11, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0651-2026
  • Class II Ongoing

    BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 25 x 26 mL applicators/case, NDC 54365-400-39, catalog number 930825NS, b) 50 x 26 mL applicators/case, NDC 54…

    Reason: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

    CareFusion 213, LLC

    Lots, distribution and details
    Product
    BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 25 x 26 mL applicators/case, NDC 54365-400-39, catalog number 930825NS, b) 50 x 26 mL applicators/case, NDC 54365-400-39, bulk catalog number 930825NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co.
    Lots / codes
    Lot: a) 3352149, Exp 12/31/2026 b) 5028798, Exp 01/31/2028, 5069651, Exp 03/31/2028.
    Distribution
    Distributed Nationwide in the USA
    Quantity
    125 units
    Recall started
    June 11, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0650-2026
  • Class II Ongoing

    BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x 10.5 mL Applicators/case, NDC 54365-400-36, catalog number 930725NS; b) 100 x 10.5 mL Applicators/case,…

    Reason: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

    CareFusion 213, LLC

    Lots, distribution and details
    Product
    BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x 10.5 mL Applicators/case, NDC 54365-400-36, catalog number 930725NS; b) 100 x 10.5 mL Applicators/case, bulk catalog number 930725NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co.
    Lots / codes
    Lot: a) 4157798, Exp 05/31/2027, 5016842, Exp 12/31/2027, 5112542, Exp 04/30/2028 b) 3330777, Exp 10/31/2026, 3345111, Exp 12/31/2026, 4037991, Exp 01/31/2027, 4114505, Exp 04/30/2027, 4156664, Exp 05/31/2027, 4270441, Exp 09/30/2027, 5078395, Exp 03/31/2028
    Distribution
    Distributed Nationwide in the USA
    Quantity
    1,200 units
    Recall started
    June 11, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0649-2026
  • Class II Ongoing

    BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as: a) 25 x 26 mL applicators/case, NDC 54365-400-38, calatog number 930815NS: b) 50 x 26 mL appliactors/case, b…

    Reason: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

    CareFusion 213, LLC

    Lots, distribution and details
    Product
    BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as: a) 25 x 26 mL applicators/case, NDC 54365-400-38, calatog number 930815NS: b) 50 x 26 mL appliactors/case, bulk catalog number 930815NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co.
    Lots / codes
    Lot: a) 3291614, Exp 10/31/2026, 4034080, 4036599, Exp 01/31/2027, 4081350, Exp 03/31/2027, 5008234, Exp 12/31/2027. b) 2320053, Exp 11/30/2025, 4151258, Exp 05/31/2027. 5084224, Exp 03/31/2028.
    Distribution
    Distributed Nationwide in the USA
    Quantity
    400 units
    Recall started
    June 11, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0648-2026
  • Class II Ongoing

    BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x 3 mL applicators/case, NDC 54365-400-33, calatog 930415NS: b) 250 x 3mL applicators/case, bulk catal…

    Reason: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

    CareFusion 213, LLC

    Lots, distribution and details
    Product
    BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x 3 mL applicators/case, NDC 54365-400-33, calatog 930415NS: b) 250 x 3mL applicators/case, bulk catalog number 930415NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co.
    Lots / codes
    Lot: a) 3194046, Exp. 06/30/2026, 3217036, Exp 07/31/2026, 3279434, Exp 09/30/2026, 3286268, 3304460, Exp 10/31/2026, 3346277, Exp 11/30/2026, 4031686, 4039656, Exp 01/31/2027, 4048949, 4060437, 4067207, Exp 02/28/2027, 4092773, 4094978, 4106623, Exp 03/31/2027, 4120371, 4129596, Exp 04/30/2027, 4144918, Exp 05/31/2027, 4193623 4200771, Exp 06/30/2027, 4227747, 4250845, Exp 08/31/2027, 50872610, 5093809, Exp 03/31/2028, 5121323, Exp 04/30/2028. b) 3331331, Exp 11/30/2026, 4284935, Exp 10/31/2027, 4344682, Exp 11/30/2027, 5015852, Exp 01/31/2028, 5086227, Exp 03/31/2028.
    Distribution
    Distributed Nationwide in the USA
    Quantity
    7,650 units
    Recall started
    June 11, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0647-2026
  • Class II Ongoing

    ChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 500 x 1.5 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC…

    Reason: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

    CareFusion 213, LLC

    Lots, distribution and details
    Product
    ChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 500 x 1.5 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-30, Catalog number 930599NSB
    Lots / codes
    Lot: 3279063, Exp. 9/30/2026, 3319524, 3324094, 3343541, Exp. 11/30/2026, 3357638, 4010202,Exp. 12/31/2026, 4206771, Exp. 7/31/2027, 4267824, 4270191, 4282285, Exp.9/30/2027, 4338352, Exp. 11/30/2027, 5053657, Exp. 2/29/2028, 5121340, Exp. 4/30/2028.
    Distribution
    Distributed Nationwide in the USA
    Quantity
    10,500 units
    Recall started
    June 11, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0646-2026
  • Class II Ongoing

    BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG), and 70% v/v isopropyl alcohol (IPA), Packaged as a) 100 x 3ml applicators/case, NDC 54365-400-32, catalog 930400NS; b) 250 x 3ml applicators/case, NDC 54365-400…

    Reason: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

    CareFusion 213, LLC

    Lots, distribution and details
    Product
    BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG), and 70% v/v isopropyl alcohol (IPA), Packaged as a) 100 x 3ml applicators/case, NDC 54365-400-32, catalog 930400NS; b) 250 x 3ml applicators/case, NDC 54365-400-32, bulk Catalog 930500NSB, Sterile Solution, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co.
    Lots / codes
    Lot: (a) 3214024, 3199359, 3200136, Exp 6/30/2026, 3212372, Exp. 7/31/2026, 3237018, 3243267, 3264290, Exp. 8/31/2026, 3313291, Exp. 10/31/2026, 3334121, Exp. 11/30/2026, 4030693, 4033380, Exp 1/31/2027, 4058103, 4065931, Exp. 2/28/2027, 4093245, 4094302, Exp. 3/31/2027, 4145548, 4146564, Exp. 5/31/2027, 4191049, Exp 6/30/2027, 4214794, 4218807, Exp. 7/31/2027, 4249036, Exp. 8/31/2027, 4254217, 4330005, 4277387, 4275877, 4276225, 4276231, Exp. 9/30/2027, 4304554, 4304577, 4305852, Exp. 10/31/2027, 4332555, Exp. 11/30/2027, 4348701, 4366429, Exp. 12/31/2027, 5016607, 5016609, 5017377, 5018775, Exp. 1/31/2028, 5050801, 5050107, Exp. 2/29/2028, 5076869, 5077722, 5079413, Exp. 3/31/2028, 5112405, 5106576, 5111556, 5118607, 5119243, 5119244, 5127658, Exp. 4/30/2028, 5139589, 5154809, 5157377, Exp. 5/31/2028, 5160633, 5160695, 5177477, Exp.6/30/2028, 5195773, 5195785, 5210771, 5210773, 5210784, 5219294, Exp. 7/31/2028, 5233581, 5247554, 5247987, Exp. 8/31/2028, 5310578, Exp.10/31/2028, 5338383, Exp.11/30/2028, 5343740, 6008264, Exp. 12/31/2028, 6009889, 6031246, 6033968, Exp. 1/31/2029, 6041203, 6059301, 6061876, Exp. 2/28/2029, (b) 3293904, Exp. 10/31/2026, 3333265, Exp. 11/30/2026, 4031672, 1/31/2027, 4061583, 4068589, Exp. 2/28/2027, 4081770, Exp. 3/31/2027, 4154588, 4166005, Exp. 5/31/2027, 4213945, 4215736, Exp. 7/31/2027, 4241055, Exp. 8/31/2027, 4262802, 4270628, Exp. 9/30/2027, 4309640, Exp. 10/31/2027, 5114931, Exp. 4/30/2028, 5135055, 5136752, 5143453, Exp. 5/31/2028, 5165652, Exp. 6/30/2028.
    Distribution
    Distributed Nationwide in the USA
    Quantity
    146,600 units
    Recall started
    June 11, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0645-2026

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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