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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 III Ongoing

    busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, Ghazibad – 201 003, India Manufactured for: Unichem Pharmaceuticals (USA), Inc. Ea…

    Reason: Subpotent drug

    Unichem Pharmaceuticals USA Inc. · Buspirone Hydrochloride

    Lots, distribution and details
    Product
    busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, Ghazibad – 201 003, India Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816, NDC 29300-244-05.
    Lots / codes
    Lot: ZBUL25001, Exp 12/31/2027
    Distribution
    USA Nationwide
    Quantity
    10,875 Bottles
    Recall started
    April 13, 2026 (Voluntary: Firm initiated)
    Severity
    Not likely to cause health problems — for example a labelling or packaging fault.
    FDA recall number
    D-0511-2026
  • Class II Ongoing

    Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0282-59.

    Reason: This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.

    Hikma Pharmaceuticals USA INC · Alendronate Sodium

    Lots, distribution and details
    Lots / codes
    Lot # AC2040A, Exp Date: 04/2026
    Distribution
    US Nationwide.
    Quantity
    4 single dose 75 ml bottles
    Recall started
    April 7, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0526-2026
  • Class III Ongoing

    Lidocaine Wound Gel (Benzalkonium Chloride, 0.13% and Lidocaine Hydrochloride, 2%), NET WT 0.5 OZ (14 g), Distributed by: CVS PHarmacy, INc., One CVS Drive, Woonsocket, RI 02895. NDC 59898-950

    Reason: Failed PH Specifications

    Water-Jel Technologies, LLC

    Lots, distribution and details
    Lots / codes
    Lots: A5014, A5018, A5019
    Distribution
    Nationwide in the USA
    Quantity
    31,488 tubes
    Recall started
    April 7, 2026 (Voluntary: Firm initiated)
    Severity
    Not likely to cause health problems — for example a labelling or packaging fault.
    FDA recall number
    D-0509-2026
  • Class II Ongoing

    fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 mcg per mL), wells pharma, NDC 73702-202-15.

    Reason: cGMP deviations.

    Wells Pharma of Houston LLC

    Lots, distribution and details
    Lots / codes
    Lot 020226202150202, Exp Date 05/05/2026.
    Distribution
    U.S. Nationwide.
    Quantity
    50 syringes
    Recall started
    April 1, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0508-2026
  • Class II Ongoing

    Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Kitty Drive, Houston, TX 77054, NDC 73702-302-31.

    Reason: cGMP deviations.

    Wells Pharma of Houston LLC · Ketamine Hydrochloride

    Lots, distribution and details
    Product
    Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Kitty Drive, Houston, TX 77054, NDC 73702-302-31.
    Lots / codes
    120925302312764, Exp Date 04/09/2026, 123125302312879 Exp Date, 05/05/2026, 123125302312880, Exp Date 05/05/2026, 010226302310003, Exp Date 05/06/2026, 010626302310007, Exp Date 05/08/2026, 010626302310008, Exp Date 05/08/2026 020426302310243, Exp Date 06/06/2026.
    Distribution
    U.S. Nationwide.
    Quantity
    4975 syringes
    Recall started
    April 1, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0507-2026
  • Class II Ongoing

    fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per mL), well pharma of Houston, NDC 73702-203-65.

    Reason: cGMP deviations.

    Wells Pharma of Houston LLC

    Lots, distribution and details
    Product
    fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per mL), well pharma of Houston, NDC 73702-203-65.
    Lots / codes
    Lot 022326203650432; Exp Date 06/25/2026
    Distribution
    U.S. Nationwide.
    Quantity
    150 syringes
    Recall started
    April 1, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0506-2026
  • Class II Ongoing

    fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg per mL), 25 mL, wells pharma of Houston, NDC 73702-204-25.

    Reason: cGMP deviations.

    Wells Pharma of Houston LLC · Fentanyl Citrate

    Lots, distribution and details
    Lots / codes
    Lot 011226204250063, Exp Date 05/14/2026
    Distribution
    U.S. Nationwide.
    Quantity
    50 syringes
    Recall started
    April 1, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0505-2026
  • Class II Ongoing

    fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (10 mcg per mL), 250 mL bag, wells pharma of Houston, NDC 73702-202-03.

    Reason: cGMP deviations.

    Wells Pharma of Houston LLC

    Lots, distribution and details
    Lots / codes
    120125202032701, Exp Date 04/01/2026; 122625202032857, Exp Date 04/25/2026; 122625202032862, Exp Date 04/28/2026, 122625202032863. Exp Date 04/28/2026; 122625202032864, Exp Date 04/28/2026; 122625202032865, Exp Date 04/28/2026, 011226202030062, Exp Date 05/14/2026, 011326202030776, Exp Date 05/15/2026; 011326202030077, Exp Date 05/15/2026, 011626202030111, Exp Date 05/20/2026, 011926202030122, Exp Date 05/21/2026; 011926202030123, Exp Date 05/21/2026, 012726202030159, Exp Date 05/28/2026, 020226202030200, Exp Date 06/04/2026, 020326202030216, Exp Date 06/05/2026, 020426202030234, Exp Date 06/06/2026, 02182202030398, Exp Date 06/20/2026.
    Distribution
    U.S. Nationwide.
    Quantity
    2940 IV Bags
    Recall started
    April 1, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0504-2026
  • Class II Ongoing

    fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per mL), 100 mL bag, Wells Pharma in Houston, NDC 73702-202-02.

    Reason: cGMP deviations.

    Wells Pharma of Houston LLC · Fentanyl Citrate

    Lots, distribution and details
    Lots / codes
    120925202022769, Expiration Date 04/09/2026, 123125202022883, Expiration Date 05/05/2026, 123125202022884, Expiration Date 05/05/2026 011226202020057, Expiration Date 05/14/2026, 011226202020058, Expiration Date 05/14/2026, 011626202020110, Expiration Date 05/20/2026 012726202020156, Expiration Date 05/28/2026. 012726202020161, Expiration Date 05/28/2026 020226202020195, Expiration Date 06/04/2026 021826202020386, Expiration Date 06/20/2026 022026202020417, Expiration Date 06/24/2026 022026202020424 Expiration Date 06/24/2026
    Distribution
    U.S. Nationwide.
    Quantity
    4,030 IV Bags
    Recall started
    April 1, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0503-2026
  • Class II Ongoing

    Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma of Houston, NDC 73702-122-03

    Reason: cGMP deviations.

    Wells Pharma of Houston LLC · Phenylephrine Hydrochloride

    Lots, distribution and details
    Lots / codes
    120325122032719, Exp Date 04/03/2026, 120425122032734 Exp Date 04/04/2026, 120425122032735, Exp Date 04/04/2026, 120925122032781, Exp Date 04/10/2026, 010626122030010, Exp Date, 05/08/2026, 010626122030009, Exp Date 05/08/2026, 010826122030031, Exp Date 05/13/2026, 010826122030032, Exp Date 05/13/2026, 011326122030072, Exp Date 05/15/2026, 011326122030071, Exp Date 05/15/2026, 011626122030107, Exp Date 05/20/2026, 011626122030106, Exp Date 05/20/2026, 011926122030118, Exp. Date, 05/21/2026, 011926122030119, Exp Date, 05/21/2026, 012726122030171, Exp Date, 05/29/2026, 012726122030170, Exp Date 05/29/2026, 012826122030181, Exp Date 05/30/2026, 012826122030182, Exp Date 05/30/2026, 020226122030201, Exp Date 06/04/2026, 020326122030217, Exp Date 06/05/2026, 020426122030235, Exp Date 06/06/2026, 020426122030242, Exp Date 06/06/2026, 020426122030241, Exp Date 06/06/2026, 020626122030260, Exp Date 06/09/2026, 020626122030256, Exp Date 06/09/2026, 020926122030303, Exp Date 06/11/2026, 021026122030308, Exp Date, 06/12/2026, 021126122030321, Exp Date 06/13/2026, 021126122030316, Exp Date 06/13/2026, 021226122030326, Exp Date 06/16/2026, 021326122030341, Exp Date 06/17/2026, 021726122030366, Exp Date 06/19/2026, 021726122030369, Exp Date 06/19/2026, 021826122030388, Exp Date 06/20/2026, 022026122030421, Exp Date 06/24/2026, 022026122030420, Exp Date 06/24/2026, 022326122030435, Exp Date, 06/25/2026, 031026122030552, Exp Date 07/10/2026, 031026122030553, Exp Date 07/10/2026
    Distribution
    U.S. Nationwide.
    Quantity
    13,070 IV Bags
    Recall started
    April 1, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0502-2026
  • Class II Ongoing

    Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 59262-700-11

    Reason: Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.

    Thea Pharma, Inc.

    Lots, distribution and details
    Lots / codes
    Lot# 5S30B, 5S30C, Exp Date: April 30, 2026; Lot# 5S31B, 6S57B, Exp Date: May 31, 2026.
    Distribution
    Nationwide within the United States
    Quantity
    —
    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-0501-2026
  • Class II Ongoing

    iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 82584-700-11

    Reason: Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.

    Thea Pharma, Inc.

    Lots, distribution and details
    Lots / codes
    Lot#: 3T36B, Exp. Date October 31, 2026.
    Distribution
    Nationwide within the United States
    Quantity
    —
    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-0500-2026
  • Class II Ongoing

    Optase Dry Eye Intense Drops (Glycerin 0.2%), packaged in 0.33 fl oz, Sterile, Manufactured for Scope Health Inc., 79 Madison Ave., 8th Floor, New York, NY 10016, USA, NDC 72972-002-01.

    Reason: Lack of Assurance of Sterility

    SCOPE HEALTH

    Lots, distribution and details
    Lots / codes
    Lot#: 8T98, 9T31, 9T32, Exp. Date: 30/04/26; 2V13, 2V14, 2V15, Exp. Date 30/06/26; 3V35, Exp. Date 31/08/26;3V36, 3V37, Exp. Date 30/09/26; 5V45, 5V46, 9V12, Exp. Date 31/03/27; 1X57, 1X70, 1X84, Exp. Date 31/05/27.
    Distribution
    Nationwide within the United States
    Quantity
    —
    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-0499-2026
  • Class III Ongoing

    Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC: 0517-1045-01

    Reason: Labeling: Missing Label

    American Regent, Inc. · Levocarnitine

    Lots, distribution and details
    Product
    Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC: 0517-1045-01
    Lots / codes
    Lot 24159N0C0, Exp. June 30, 2026 Lot 25193N0C0, Exp. July 31, 2027
    Distribution
    U.S. Nationwide
    Quantity
    74,040 Single Dose Vials
    Recall started
    April 16, 2026 (Voluntary: Firm initiated)
    Severity
    Not likely to cause health problems — for example a labelling or packaging fault.
    FDA recall number
    D-0494-2026
  • Class II Ongoing

    GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alcon Laboratories, Inc., Fort Worth, Texas 76134, USA, NDC: 0065-8064-01.

    Reason: Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.

    Alcon Research LLC

    Lots, distribution and details
    Lots / codes
    Lot #: 9T20, 9T50, 9T59, 1U30, 1U48, Exp Date: 4/30/2026; 4V15, Exp Date: 8/31/2026; 7V61, Exp Date: 12/31/2026; 1W47, 1W49, 1X14, Exp Date: 3/31/2027.
    Distribution
    Nationwide within the United States
    Quantity
    —
    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-0492-2026
  • Class II Ongoing

    Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Laboratiroes, Inc., Fort Worth, TX 76134, USA, NDC 0065-0474-01

    Reason: Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.

    Alcon Research LLC

    Lots, distribution and details
    Lots / codes
    Lot#: 9T21, Exp Date: 4/30/2026; Lot# 1U63, 2U47, Exp Date: 5/31/2026; Lot# 6V00, 6V12, 8V54, Exp Date: 1/31/2027; Lot# 9V55, 8V58, 9V39, 9V97, Exp Date: 2/28/2027; Lot# 1W39, 1W40, Exp Date: 3/31/2027; Lot# 1X76, Exp Date: 4/30/2027.
    Distribution
    Nationwide within the United States
    Quantity
    —
    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-0491-2026
  • Class II Ongoing

    Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10×10 blister packs NDC 0555-1054-60; b) 30-count carton, NDC 0555-1054-86, with 3X10 blister pack NDC 0555-1054-60; Rx…

    Reason: Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin

    Teva Pharmaceuticals USA, Inc · Isotretinoin

    Lots, distribution and details
    Product
    Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10×10 blister packs NDC 0555-1054-60; b) 30-count carton, NDC 0555-1054-86, with 3X10 blister pack NDC 0555-1054-60; Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
    Lots / codes
    Lots#: 100067507, 100067508, Exp 07/31/2026
    Distribution
    Nationwide in the USA, Puerto Rico and Virgin Islands
    Quantity
    5,101 cartons
    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-0521-2026
  • Class II Ongoing

    LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7389-60.

    Reason: Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

    B BRAUN MEDICAL INC

    Lots, distribution and details
    Lots / codes
    Lot # J5E234, J5E236, Exp Date: 30APR2028; Lot # J5H158, J5H159, J5H160, J5H161, J5H162, J5H163, J5H174, J5H175, Exp Date: 31MAY2028.
    Distribution
    US Nationwide.
    Quantity
    54,540 bags
    Recall started
    April 2, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0498-2026
  • Class II Ongoing

    0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7388-60.

    Reason: Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

    B BRAUN MEDICAL INC

    Lots, distribution and details
    Lots / codes
    Lot # J5E226, J5E227, J5E228, J5E229, J5E230, J5E231, J5E232, J5E233, J5E238, J5E239, Exp Date: 30Apr2028, Lot # J5E240, J5E241, J5E242, J5E243, J5E244, J5E245, J5E247, J5E248, Exp Date: 30Apr2028, Lot # J5H151, J5H152, J5H153, J5H154, J5H155, Exp Date: 31 May2028.
    Distribution
    US Nationwide.
    Quantity
    124,244 bags
    Recall started
    April 2, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0497-2026
  • Class II Ongoing

    DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7387-50.

    Reason: Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

    B BRAUN MEDICAL INC

    Lots, distribution and details
    Lots / codes
    Lot # J5H166, J5H167, Exp Date: 30NOV2026.
    Distribution
    US Nationwide.
    Quantity
    17,124 bags
    Recall started
    April 2, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0496-2026
  • Class II Ongoing

    Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehem, PA 18018-3524, NDC: 0264-7385-60.

    Reason: Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

    B BRAUN MEDICAL INC

    Lots, distribution and details
    Lots / codes
    Lot # J5H165, Exp Date: 31 May2028; Lot # J5E237, Exp Date: 30APR2028.
    Distribution
    US Nationwide.
    Quantity
    24,928 bags
    Recall started
    April 2, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0495-2026
  • Class II Ongoing

    Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46288. NDC: 0904-7495-06

    Reason: Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.

    The Harvard Drug Group LLC · Omega-3-Acid Ethyl Esters

    Lots, distribution and details
    Product
    Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46288. NDC: 0904-7495-06
    Lots / codes
    Lot#: Lot N02406, Exp 10/31/2026; Lot N02845, Exp 12/31/2026
    Distribution
    Nationwide in the USA
    Quantity
    2,238 5 x 10 unit dose cartons
    Recall started
    April 9, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0493-2026
  • Class III Ongoing

    Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Romano Drive, Plymouth Meeting, PA 19462, NDC 48783-112-08.

    Reason: Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that this error is limited to the vial itself; the saleable unit of the box of 12 bottles has the correct expiration date printed.

    Premier Dental Products Co · Ferric Subsulfate

    Lots, distribution and details
    Lots / codes
    Lot #: 640911253, Exp Date. 09/14/2027.
    Distribution
    Nationwide within the United States
    Quantity
    573 cartons
    Recall started
    April 14, 2026 (Voluntary: Firm initiated)
    Severity
    Not likely to cause health problems — for example a labelling or packaging fault.
    FDA recall number
    D-0490-2026
  • Class II Ongoing

    FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.

    Reason: Lack of Assurance of Sterility

    Harrow Eye LLC

    Lots, distribution and details
    Lots / codes
    Lot #: 1X68, 1X69, Exp. Date 05/31/2027.
    Distribution
    Nationwide within the United States
    Quantity
    50,900 units
    Recall started
    April 17, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0489-2026
  • Class II Ongoing

    Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01

    Reason: CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.

    Leading Pharma, LLC · Furosemide

    Lots, distribution and details
    Lots / codes
    Lots# H03125, H03225, H03325, Exp Date: 2027/08
    Distribution
    US Nationwide.
    Quantity
    9384 bottles
    Recall started
    March 20, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0486-2026

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.

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