Advertisement



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

    Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.

    Reason: Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.

    Haleon US Holdings LLC

    Lots, distribution and details
    Lots / codes
    Lot: KB5Y, Expires: 04/2028; MP4B, Expires: 05/2028; SS4F, Expires: 09/2028.
    Distribution
    U.S. Nationwide.
    Quantity
    285,330 blister cards
    Recall started
    May 11, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0542-2026
  • Class II Ongoing

    Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur 441108, INDIA, a) 2 Pens- NDC 70748-346-02; b) 3 Pens – NDC 70…

    Reason: Presence of particulate matter: a white thread-like structure in the cartridge

    Lupin Pharmaceuticals Inc. · Liraglutide

    Lots, distribution and details
    Product
    Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur 441108, INDIA, a) 2 Pens- NDC 70748-346-02; b) 3 Pens – NDC 70748-346-03.
    Lots / codes
    Lots: a) WB00097, WB00094, WB00088, Expires: Jul. 2027; WB00103, Expires: Oct. 2027; WC00016, Expires: Dec. 2027; b) WB00098, WB00092, WB00093, Expires: Jul. 2027; WB00104, WB00106, WB00105, Expires: Oct. 2027.
    Distribution
    Nationwide within U.S
    Quantity
    217,621 pen injectors
    Recall started
    April 24, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0541-2026
  • Class III Ongoing

    Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8×10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, Made in Canada, NDC 25021-241-10.

    Reason: Failed Impurities/Degradation Specifications

    Sagent Pharmaceuticals · Busulfan

    Lots, distribution and details
    Lots / codes
    Lot #: 656412, Exp. Date 08/31/2026; 659646, Exp. Date 03/31/2027.
    Distribution
    Nationwide within the United States
    Quantity
    Lot 656412: 6,200 vials. Lot 659646: 3,328 vials.
    Recall started
    May 4, 2026 (Voluntary: Firm initiated)
    Severity
    Not likely to cause health problems — for example a labelling or packaging fault.
    FDA recall number
    D-0539-2026
  • Class II Ongoing

    Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by: Safecor, Columbus, OH 43204. NDC: 64380-474-01

    Reason: Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.

    Safecor Health, LLC · Atomoxetine

    Lots, distribution and details
    Product
    Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by: Safecor, Columbus, OH 43204. NDC: 64380-474-01
    Lots / codes
    Lot #: 25530722
    Distribution
    TX only
    Quantity
    149 capsules
    Recall started
    April 30, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0538-2026
  • Class III Ongoing

    Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-11

    Reason: Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

    Amerisource Health Services LLC · Primidone

    Lots, distribution and details
    Product
    Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-11
    Lots / codes
    Lot 1028739, exp 12/31/2027; Lot 1025622, exp 06/30/2027
    Distribution
    USA Nationwide
    Quantity
    225,000 tablets
    Recall started
    May 1, 2026 (Voluntary: Firm initiated)
    Severity
    Not likely to cause health problems — for example a labelling or packaging fault.
    FDA recall number
    D-0537-2026
  • Class III Ongoing

    Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-203-01; Individual Dose NDC: 68084-203-11

    Reason: Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

    Amerisource Health Services LLC · Primidone

    Lots, distribution and details
    Product
    Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-203-01; Individual Dose NDC: 68084-203-11
    Lots / codes
    Lot#: 1027583, Exp 09/30/2027
    Distribution
    USA Nationwide
    Quantity
    63,500 tablets
    Recall started
    May 1, 2026 (Voluntary: Firm initiated)
    Severity
    Not likely to cause health problems — for example a labelling or packaging fault.
    FDA recall number
    D-0536-2026
  • Class III Ongoing

    Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-638-01

    Reason: Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

    Golden State Medical Supply Inc. · Primidone

    Lots, distribution and details
    Product
    Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-638-01
    Lots / codes
    Lot #: GS067909, Exp 4/30/2028; GS068646, Exp 8/31/2026
    Distribution
    USA Nationwide
    Quantity
    1,620 bottles
    Recall started
    April 27, 2026 (Voluntary: Firm initiated)
    Severity
    Not likely to cause health problems — for example a labelling or packaging fault.
    FDA recall number
    D-0535-2026
  • Class III Ongoing

    Primidone Tablets, USP, 50 mg, 50-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-637-05

    Reason: Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

    Golden State Medical Supply Inc. · Primidone

    Lots, distribution and details
    Product
    Primidone Tablets, USP, 50 mg, 50-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-637-05
    Lots / codes
    Lot#: GS066750, GS067084, GS067710, GS067873, Exp 3/31/2028; GS068339, GS068897, Exp 8/31/2028
    Distribution
    USA Nationwide
    Quantity
    8,526 bottles
    Recall started
    April 27, 2026 (Voluntary: Firm initiated)
    Severity
    Not likely to cause health problems — for example a labelling or packaging fault.
    FDA recall number
    D-0534-2026
  • Class III Ongoing

    Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.

    Reason: Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

    Lannett Company Inc. · Primidone

    Lots, distribution and details
    Lots / codes
    Lot#: 25283038A, Exp 1/31/2028; 25283564A, 25283565A, Exp 3/31/2028; 25285712A Exp 08/31/2028; 25284105A, Exp 4/30/2028; 25284874A, 25284875A, Exp 08/31/2028.
    Distribution
    USA Nationwide
    Quantity
    44865 bottles
    Recall started
    April 24, 2026 (Voluntary: Firm initiated)
    Severity
    Not likely to cause health problems — for example a labelling or packaging fault.
    FDA recall number
    D-0533-2026
  • Class II Ongoing

    Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-590…

    Reason: Failed Dissolution Specifications

    Ascend Laboratories, LLC

    Lots, distribution and details
    Product
    Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-590-01.
    Lots / codes
    Lot # 25140859; Exp. Date: Jan 2027
    Distribution
    U.S. Nationwide
    Quantity
    17,304 100-count bottles
    Recall started
    April 27, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0547-2026
  • Class II Ongoing

    Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5×1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.

    Reason: Crystallization; identified as Buprenorphine free base

    ENDO USA, Inc. · Buprenorphine Hydrochloride

    Lots, distribution and details
    Lots / codes
    Lot #: 84132, Exp 02/28/2027; 87693, Exp 03/31/2027
    Distribution
    USA Nationwide
    Quantity
    34,293 vials
    Recall started
    March 13, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0527-2026
  • Class II Ongoing

    Oasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle, Sterile, Manufactured for: OASIS Medical, Inc., 514 S. Vermont Ave., Glendora, CA 91741, USA, Made in France, NDC 42126-6400-1.

    Reason: Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision.

    Oasis Medical, Inc.

    Lots, distribution and details
    Lots / codes
    Lot # 1V59, Exp Date: 05/31/26; Lot # 3V12, 3V69, Exp Date: 08/31/26.
    Distribution
    Nationwide within the United States
    Quantity
    —
    Recall started
    April 27, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0525-2026
  • Class I Ongoing

    Lactated Ringer's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07.

    Reason: Presence of Particulate Matter.

    B BRAUN MEDICAL INC

    Lots, distribution and details
    Lots / codes
    Lot #:J4P756, J4S843, Exp 5/31/2027
    Distribution
    U.S.A. Nationwide
    Quantity
    95,412 containers
    Recall started
    April 28, 2026 (Voluntary: Firm initiated)
    Severity
    Most serious: use could cause serious health problems or death.
    FDA recall number
    D-0540-2026
  • Class II Ongoing

    TPN bag (patient specific), Rx# 11-4909703-0-1, Compound Volume 1660 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Los Angeles, 13128 Imperial Hwy, Santa Fe Spr.…

    Reason: Incorrect Product Formulation: product did not contain insulin as listed in the label.

    Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles

    Lots, distribution and details
    Product
    TPN bag (patient specific), Rx# 11-4909703-0-1, Compound Volume 1660 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Los Angeles, 13128 Imperial Hwy, Santa Fe Spr., CA 90670
    Lots / codes
    Lot #: 11-4909703-0-1, Exp 12/28/2025
    Distribution
    CA
    Quantity
    1 bag
    Recall started
    December 27, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0524-2026
  • Class II Ongoing

    NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, Made in Canada NDC 42192-619-16

    Reason: Chemical contamination; presence of lead and lithium above specification

    Acella Pharmaceuticals, LLC · Naproxen

    Lots, distribution and details
    Product
    NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, Made in Canada NDC 42192-619-16
    Lots / codes
    Lot: 23F02, Expires: 05/2026; 25A37, Expires: 01/2028.
    Distribution
    Nationwide
    Quantity
    6,336 bottles
    Recall started
    April 20, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0523-2026
  • Class II Ongoing

    Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heights, NJ 07922, N…

    Reason: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

    Breckenridge Pharmaceutical, Inc. · Duloxetine Hydrochloride

    Lots, distribution and details
    Product
    Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heights, NJ 07922, NDC 51991-748-90.
    Lots / codes
    Lot: 241069C, Exp 05/31/2027
    Distribution
    Nationwide in the USA
    Quantity
    165,761 90-count bottles
    Recall started
    April 21, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0522-2026
  • Class II Ongoing

    Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India, Distributed by: Rising Pha…

    Reason: Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test

    JB Chemicals and Pharmaceuticals Ltd · Enalapril Maleate

    Lots, distribution and details
    Product
    Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 64980-688-10.
    Lots / codes
    Lot #: GEH25023, Expires: 6/30/2027
    Distribution
    Nationwide in the USA
    Quantity
    675 bottles
    Recall started
    April 23, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0520-2026
  • Class II Ongoing

    Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL vial of 30 mg strength, a pre-filled syringe containing 2 mL of diluent, one vial adapter, and one…

    Reason: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.

    Teva Pharmaceuticals USA, Inc · Octreotide Acetate

    Lots, distribution and details
    Product
    Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL vial of 30 mg strength, a pre-filled syringe containing 2 mL of diluent, one vial adapter, and one sterile 1¿ 19-gauge safety injection needle, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 69300 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054. NDC Kit Carton: 0480-9262-08; Vial Label: 0480-9260-01; Tray Label: 0480-9262-08; Diluent Label: 0480-9263-21.
    Lots / codes
    Lot: 45011002, Exp. 03/31/2027
    Distribution
    Nationwide in the USA
    Quantity
    2,200 kits
    Recall started
    April 24, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0519-2026
  • Class II Ongoing

    BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 0.36 fl. oz. (10.5 mL) x 25 applicators per box. Carefusion 213, LLC, El Paso, TX 79912, subsidary of Becto…

    Reason: Lack of assurance of Sterility: potential product contamination

    CareFusion 213, LLC

    Lots, distribution and details
    Product
    BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 0.36 fl. oz. (10.5 mL) x 25 applicators per box. Carefusion 213, LLC, El Paso, TX 79912, subsidary of Becton Dickinson and Co. NDC 54365-014-41
    Lots / codes
    Lots# 4263873, Exp. Date 08-31-2026, 4320590, Exp. Date 09-30-2026, 4320591, Exp. Date 10-31-2026.
    Distribution
    Nationwide in the USA
    Quantity
    —
    Recall started
    April 22, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0518-2026
  • Class II Ongoing

    BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 25x26mL Applicators per carton. Carefusion 213 LLC, El Paso, TX 79912, NDC 54365-014-42.

    Reason: Lack of assurance of Sterility: potential product contamination

    CareFusion 213, LLC

    Lots, distribution and details
    Lots / codes
    Lot# 4258309, 4260329, 4256875, Exp. Date, 08-31-2026; 4296453, 4317319, 4290654, Exp. Date 09-30-2026; 4322449, 4323861, 4318679, Exp Date 10-31- Exp.
    Distribution
    Nationwide in the USA
    Quantity
    —
    Recall started
    April 22, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0517-2026
  • Class II Ongoing

    Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-097-06.

    Reason: CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.

    Ajanta Pharma Ltd. · Duloxetine

    Lots, distribution and details
    Lots / codes
    Lot#: PA10734, Exp. Jun 2026.
    Distribution
    Nationwide within U.S
    Quantity
    117,168 packs
    Recall started
    April 29, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0516-2026
  • Class II Ongoing

    Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-099-03

    Reason: CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.

    Ajanta Pharma Ltd. · Duloxetine

    Lots, distribution and details
    Lots / codes
    Lot#: PA07434, Exp. May 2026.
    Distribution
    Nationwide within U.S
    Quantity
    77,376 packs.
    Recall started
    April 29, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0515-2026
  • Class II Ongoing

    Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03, c) 1000 Capsules, NDC 27241-098-10, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Mad…

    Reason: CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.

    Ajanta Pharma Ltd. · Duloxetine

    Lots, distribution and details
    Product
    Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03, c) 1000 Capsules, NDC 27241-098-10, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India
    Lots / codes
    Lot#: a) PA10774, Exp. May 2026; b) PA10794, PA12174, Exp. Jun 2026; c) PA10804, Exp. Jun-26.
    Distribution
    Nationwide within U.S
    Quantity
    312,894 packs
    Recall started
    April 29, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0514-2026
  • Class II Ongoing

    DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2.5% DEX. LM/LC, 2L 5PK, Part Number 054-20222, Fresenius Medical Care North America, 920 Winter Stre…

    Reason: Lack of Assurance of Sterility: Potential leaks from perforations in bags.

    Fresenius Medical Care Holdings, Inc.

    Lots, distribution and details
    Product
    DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2.5% DEX. LM/LC, 2L 5PK, Part Number 054-20222, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.
    Lots / codes
    Lots 25CU02002, 25CU02011, 25CU02012, 25CU02013
    Distribution
    Nationwide in the USA
    Quantity
    43,225 bags
    Recall started
    April 6, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0513-2026
  • Class II Ongoing

    DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% DEX. LM/LC, 2L 5PK, Part Number 054-20221, Fresenius Medical Care North America, 920 Winter Stre…

    Reason: Lack of Assurance of Sterility: Potential leaks from perforations in bags.

    Fresenius Medical Care Holdings, Inc.

    Lots, distribution and details
    Product
    DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% DEX. LM/LC, 2L 5PK, Part Number 054-20221, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.
    Lots / codes
    Lot #: 25CU02007, 25CU02008, 25CU02009
    Distribution
    Nationwide in the USA
    Quantity
    37,215 bags
    Recall started
    April 6, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0512-2026

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 November 1, 2026 02:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.

Advertisement