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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.

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

3,250 recalls

  • Class I Ongoing

    Sure Regular Antiperspirant Deodorant Aerosol (Aluminum Chlorohydrate 10%), packaged in 6 oz (170 g) aerosol cans, Distributed by Idelle Labs, Ltd., El Paso, TX 79912, NDC 41595-5518-06

    Reason: Chemical contamination: Presence of benzene

    TCP HRB ACQUISITON LLC

    Lots, distribution and details
    Lots / codes
    All lots, expiry on or before August 2023
    Distribution
    Nationwide in the US and Canada
    Quantity
    5.4 million
    Recall started
    February 16, 2022 (Voluntary: Firm initiated)
    Severity
    Most serious: use could cause serious health problems or death.
    FDA recall number
    D-0209-2024
  • Class I Ongoing

    Sure Unscented Anti-perspirant Deodorant Aerosol (Aluminum Chlorohydrate 10%), packaged in 6 oz (170 g) aerosol cans, Distributed by Idelle Labs, Ltd., El Paso, TX 79912, NDC 41595-5517-06

    Reason: Chemical contamination: Presence of benzene

    TCP HRB ACQUISITON LLC

    Lots, distribution and details
    Lots / codes
    All lots, expiry on or before August 2023
    Distribution
    Nationwide in the US and Canada
    Quantity
    0.5 million
    Recall started
    February 16, 2022 (Voluntary: Firm initiated)
    Severity
    Most serious: use could cause serious health problems or death.
    FDA recall number
    D-0208-2024
  • Class I Ongoing

    Brut Classic Antiperspirant & Deodorant (aluminum chlorohydrate 20.9%) packaged in a) 4 oz. (113g) aerosol cans (UPC 00827755070085, NDC 41595-7103-1) and b) 6 oz. (170g) aerosol cans (UPC 00827755070108, NDC 41595-7103-…

    Reason: Chemical contamination: Presence of benzene

    TCP HRB ACQUISITON LLC

    Lots, distribution and details
    Product
    Brut Classic Antiperspirant & Deodorant (aluminum chlorohydrate 20.9%) packaged in a) 4 oz. (113g) aerosol cans (UPC 00827755070085, NDC 41595-7103-1) and b) 6 oz. (170g) aerosol cans (UPC 00827755070108, NDC 41595-7103-2), Distributed by Idelle Labs, Ltd. El Paso, TX 79912 USA
    Lots / codes
    All lots, expiry on or before August 2023
    Distribution
    Nationwide in the US and Canada
    Quantity
    a) 0.4 million cans, b) 3.4 million cans
    Recall started
    February 16, 2022 (Voluntary: Firm initiated)
    Severity
    Most serious: use could cause serious health problems or death.
    FDA recall number
    D-0207-2024
  • Class I Ongoing

    Magnum XXL 9800, 2000 mg per capsule, 1 capsule per blister pack, Distributed by Magnum Los Angelas CA. UPC 6 45759 99300 7. Amazon's ASIN# B07P7ZH797, B07P94J3ZT, B07P6VK6N3, B076HNPZZZ

    Reason: Marketed without an approved NDA/ANDA: Magnum XXL found to contain undeclared active pharmaceutical ingredient (API) – Sildenafil.

    Meta Herbal

    Lots, distribution and details
    Lots / codes
    All Lots
    Distribution
    Nationwide in the USA. Product was sold via Amazon's Marketplace.
    Quantity
    500 blister packs
    Recall started
    November 29, 2023 (Voluntary: Firm initiated)
    Severity
    Most serious: use could cause serious health problems or death.
    FDA recall number
    D-0206-2024
  • Class II Ongoing

    Sertraline Tablets, USP 100 mg, 30 tablets per bottle, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Cipla USA, Inc., Warren, NJ 07059, Packaged by: Legacy Pharmaceutical Packaging LLC., Earth City,…

    Reason: CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.

    Legacy Pharmaceutical Packaging LLC · Sertraline Hydrochloride

    Lots, distribution and details
    Product
    Sertraline Tablets, USP 100 mg, 30 tablets per bottle, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Cipla USA, Inc., Warren, NJ 07059, Packaged by: Legacy Pharmaceutical Packaging LLC., Earth City, MO 63045, NDC# 68645-523-54
    Lots / codes
    Lot #: 222033, exp. date 08/31/2024
    Distribution
    CA and AR
    Quantity
    161,664 bottles
    Recall started
    December 11, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0205-2024
  • Class II Terminated

    Thiamine HCl/Pyridoxine HCl 20 mg/mL /100mg/ml Injection Solution, 30mL Amber Glass Vial, Rx only, AnazaoHealth, 7465 W. Sunset Road, Las Vegas, NV, NDC 72682-8721-3.

    Reason: Presence of Particulate Matter.

    AnazaoHealth Corporation

    Lots, distribution and details
    Lots / codes
    Lots: 508029, Exp: 12/14/23; 513191, Exp: 12/22/23; 524670, Exp: 01/12/24; 526254, Exp: 01/13/24; 530738, Exp: 01/19/23; 533570, Exp: 01/25/24; 538736, Exp: 02/03/24; 543220, Exp:02/16/24; 543508, Exp: 02/17/24; 545675, Exp: 02/22/24
    Distribution
    Nationwide in the USA.
    Quantity
    3,363 vials
    Recall started
    November 22, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0204-2024
  • Class II Terminated

    B-Complex, Thiamine HCI / Riboflavin / Niacinamide / Dexpanthenol / Pyridoxine HCI injection, 74/2/75/2/2 MG/ML, 30ML Sterile Multiple-Dose Vial, Rx only, AnazaoHealth, 7465 W Sunset Rd #1200, Las Vegas, NV 89113, NDC 72…

    Reason: Presence of Particulate Matter.

    AnazaoHealth Corporation

    Lots, distribution and details
    Product
    B-Complex, Thiamine HCI / Riboflavin / Niacinamide / Dexpanthenol / Pyridoxine HCI injection, 74/2/75/2/2 MG/ML, 30ML Sterile Multiple-Dose Vial, Rx only, AnazaoHealth, 7465 W Sunset Rd #1200, Las Vegas, NV 89113, NDC 72682-2230-3
    Lots / codes
    Lots: 505075, Exp: 02/05/24; 505596, Exp: 02/06/24; 506155, Exp: 02/07/24; 508103, Exp: 02/13/24; 510837, Exp: 02/19/24; 512411, Exp: 02/20/24; 514856, Exp: 02/25/24; 515642, Exp: 02/28/24; 518309, Exp: 03/05/24; 524262, 524266, Exp: 03/12/24; 524909, Exp: 03/13/24; 526526, Exp: 03/16/24; 529204, Exp: 03/18/24; 530858, Exp: 03/20/24; 535766, Exp: 03/30/24
    Distribution
    Nationwide in the USA.
    Quantity
    5,707 vials
    Recall started
    November 22, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0203-2024
  • Class II Terminated

    Inhub Wixela (fluticasone propionate and salmeterol inhalation powder, USP) 500/50MCG, 60 Doses of Inhalation Powder, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-9320-32

    Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

    CARDINAL HEALTHCARE · Fluticasone Propionate and Salmeterol

    Lots, distribution and details
    Product
    Inhub Wixela (fluticasone propionate and salmeterol inhalation powder, USP) 500/50MCG, 60 Doses of Inhalation Powder, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-9320-32
    Lots / codes
    Batch 62002532
    Distribution
    Nationwide USA
    Quantity
    1 unit
    Recall started
    January 26, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0202-2024
  • Class II Terminated

    Warfarin Sodium Tablets, USP, 5 mg, 100 Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC: 0093-1721-01

    Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

    CARDINAL HEALTHCARE · Warfarin Sodium

    Lots, distribution and details
    Product
    Warfarin Sodium Tablets, USP, 5 mg, 100 Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC: 0093-1721-01
    Lots / codes
    Batch 2323041
    Distribution
    Nationwide USA
    Quantity
    1 unit
    Recall started
    January 26, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0201-2024
  • Class II Terminated

    Warfarin Sodium Tablets, USP, 2.5 mg, 100 Tablets per bottle, Rx only, Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC: 0093-1714-01

    Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

    CARDINAL HEALTHCARE · Warfarin Sodium

    Lots, distribution and details
    Product
    Warfarin Sodium Tablets, USP, 2.5 mg, 100 Tablets per bottle, Rx only, Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC: 0093-1714-01
    Lots / codes
    Batch 2169041
    Distribution
    Nationwide USA
    Quantity
    1 unit
    Recall started
    January 26, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0200-2024
  • Class II Terminated

    Triamterene and Hydrochlorothiazide Capsules, USP, 37.5 mg/25 mg, 100 capsules per bottle, Rx Only, Distributed by: Lannett Company, Inc, Philadelphia, PA 19136. NDC 0527-1632-01

    Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

    CARDINAL HEALTHCARE · Triamterene and Hydrochlorothiazide

    Lots, distribution and details
    Product
    Triamterene and Hydrochlorothiazide Capsules, USP, 37.5 mg/25 mg, 100 capsules per bottle, Rx Only, Distributed by: Lannett Company, Inc, Philadelphia, PA 19136. NDC 0527-1632-01
    Lots / codes
    Batch 21000279A, 21000280A
    Distribution
    Nationwide USA
    Quantity
    2 units
    Recall started
    January 26, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0199-2024
  • Class II Terminated

    Terconazole Vaginal Suppositories, 80 mg, 3 Suppositories with Vaginal Applicator, Rx only, Manufactured by: Cosette Pharmaceuticals, Inc., 111 Coolidge Street, South Plainfield, NJ 07080. NDC: 0713-0552-73

    Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

    CARDINAL HEALTHCARE · Terconazole

    Lots, distribution and details
    Product
    Terconazole Vaginal Suppositories, 80 mg, 3 Suppositories with Vaginal Applicator, Rx only, Manufactured by: Cosette Pharmaceuticals, Inc., 111 Coolidge Street, South Plainfield, NJ 07080. NDC: 0713-0552-73
    Lots / codes
    Batch 1014228A
    Distribution
    Nationwide USA
    Quantity
    1 unit
    Recall started
    January 26, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0198-2024
  • Class II Terminated

    SPIRIVA HANDIHALER (tiotropium bromide inhalation powder) 18 mcg/Capsule, 30 capsules, 3 blister cards, each card contains 10 capsules, Rx only, For oral inhalation only, Distributed by: Boehringer Ingelheim Pharmaceutic…

    Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

    CARDINAL HEALTHCARE · Tiotropium Bromide

    Lots, distribution and details
    Product
    SPIRIVA HANDIHALER (tiotropium bromide inhalation powder) 18 mcg/Capsule, 30 capsules, 3 blister cards, each card contains 10 capsules, Rx only, For oral inhalation only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. NDC: 0597-0075-41
    Lots / codes
    Batch 104440
    Distribution
    Nationwide USA
    Quantity
    5 units
    Recall started
    January 26, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0197-2024
  • Class II Terminated

    RIVASTIGMINE TRANSDERMAL SYSTEM, Delivers 4.6 mg/24 hours, 30 systems per box, Rx Only, Distributed by: Alvogen, Inc., Morristown, NJ 07960. NDC 47781-304-03

    Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

    CARDINAL HEALTHCARE

    Lots, distribution and details
    Product
    RIVASTIGMINE TRANSDERMAL SYSTEM, Delivers 4.6 mg/24 hours, 30 systems per box, Rx Only, Distributed by: Alvogen, Inc., Morristown, NJ 07960. NDC 47781-304-03
    Lots / codes
    Batch P0248AL0AT
    Distribution
    Nationwide USA
    Quantity
    1 unit
    Recall started
    January 26, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0196-2024
  • Class II Terminated

    Ricola CherryHoney Herb Throat Drops (menthol, 1.8 mg), 10 Drops per roll, Manufacturer: Ricola Ltd., 4242 Laufen, Switzerland; Distributed by: Ricola USA Inc., 6 Campus Drive, 2nd Floor South, Parsippany, NJ 07054. NDC:…

    Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

    CARDINAL HEALTHCARE

    Lots, distribution and details
    Product
    Ricola CherryHoney Herb Throat Drops (menthol, 1.8 mg), 10 Drops per roll, Manufacturer: Ricola Ltd., 4242 Laufen, Switzerland; Distributed by: Ricola USA Inc., 6 Campus Drive, 2nd Floor South, Parsippany, NJ 07054. NDC: 54305-507-10
    Lots / codes
    Batch 2000058693
    Distribution
    Nationwide USA
    Quantity
    2 units
    Recall started
    January 26, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0195-2024
  • Class II Terminated

    Propranolol Hydrochloride Tablets, 20 mg, 100 Tablets per bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213, India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. ND…

    Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

    CARDINAL HEALTHCARE · Propranolol Hydrochloride

    Lots, distribution and details
    Product
    Propranolol Hydrochloride Tablets, 20 mg, 100 Tablets per bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213, India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 69238-2078-1
    Lots / codes
    Batch 100023596
    Distribution
    Nationwide USA
    Quantity
    2 units
    Recall started
    January 26, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0194-2024
  • Class II Terminated

    PredniSONE Tablets, USP, 20 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801. NDC: 59746-175-06

    Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

    CARDINAL HEALTHCARE · Prednisone

    Lots, distribution and details
    Product
    PredniSONE Tablets, USP, 20 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801. NDC: 59746-175-06
    Lots / codes
    Batch 21P0659
    Distribution
    Nationwide USA
    Quantity
    1 unit
    Recall started
    January 26, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0193-2024
  • Class II Terminated

    Nyamyc, 100,000 USP units per gram, 60 grams, Rx only, Topical Use Only, Manufactured by: Upsher-Smith Laboratories, Inc, Minneapolis, MN 55447.

    Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

    CARDINAL HEALTHCARE

    Lots, distribution and details
    Product
    Nyamyc, 100,000 USP units per gram, 60 grams, Rx only, Topical Use Only, Manufactured by: Upsher-Smith Laboratories, Inc, Minneapolis, MN 55447.
    Lots / codes
    Batch 400454
    Distribution
    Nationwide USA
    Quantity
    2 units
    Recall started
    January 26, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0192-2024
  • Class II Terminated

    Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. NDC: 45963-676-96

    Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

    CARDINAL HEALTHCARE · Metoprolol Succinate

    Lots, distribution and details
    Product
    Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. NDC: 45963-676-96
    Lots / codes
    Batch 2447J211
    Distribution
    Nationwide USA
    Quantity
    1 unit
    Recall started
    January 26, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0191-2024
  • Class II Terminated

    Meloxicam Tablets, USP, 15 mg, 1000 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., Kurkumbh, India; Manufactured for: Cipla USA, Inc., 9100 S. Dadeland Blvd., Suite 1500 Miami, FL 33156. NDC: 69097-159-15

    Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

    CARDINAL HEALTHCARE · Meloxicam

    Lots, distribution and details
    Product
    Meloxicam Tablets, USP, 15 mg, 1000 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., Kurkumbh, India; Manufactured for: Cipla USA, Inc., 9100 S. Dadeland Blvd., Suite 1500 Miami, FL 33156. NDC: 69097-159-15
    Lots / codes
    Batch KA11489
    Distribution
    Nationwide USA
    Quantity
    1 unit
    Recall started
    January 26, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0190-2024
  • Class II Terminated

    Lithium Carbonate Extended-Release Tablets, USP, 300 mg, 100 Tablets per bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-1300-01

    Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

    CARDINAL HEALTHCARE · Lithium Carbonate

    Lots, distribution and details
    Product
    Lithium Carbonate Extended-Release Tablets, USP, 300 mg, 100 Tablets per bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-1300-01
    Lots / codes
    Batch 3138326
    Distribution
    Nationwide USA
    Quantity
    1 unit
    Recall started
    January 26, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0189-2024
  • Class II Terminated

    Lisinopril and Hydrochlorothiazide Tablets USP, 10mg/12.5mg, Rx only, 100 Tablets per bottles, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Nagpur-441 108, Ind…

    Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

    CARDINAL HEALTHCARE · Lisinopril and Hydrochlorothiazide

    Lots, distribution and details
    Product
    Lisinopril and Hydrochlorothiazide Tablets USP, 10mg/12.5mg, Rx only, 100 Tablets per bottles, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Nagpur-441 108, India. NDC: 68180-518-01
    Lots / codes
    Batch Q101699, Q101981
    Distribution
    Nationwide USA
    Quantity
    2 units
    Recall started
    January 26, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0188-2024
  • Class II Terminated

    Lillow (Levonorgestrel and Ethinyl Estradiol Tablets, USP), 0.15 mg/0.03 mg, 1 Blister Pack Containing 28 Tablets, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC 69238-1554-6

    Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

    CARDINAL HEALTHCARE

    Lots, distribution and details
    Product
    Lillow (Levonorgestrel and Ethinyl Estradiol Tablets, USP), 0.15 mg/0.03 mg, 1 Blister Pack Containing 28 Tablets, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC 69238-1554-6
    Lots / codes
    Batch A5921
    Distribution
    Nationwide USA
    Quantity
    1 unit
    Recall started
    January 26, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0187-2024
  • Class II Terminated

    Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg), 18 Tablets per cartons, Distributed By Cardinal Health, Dublin, Ohio 43017. NDC: 70000-0126-1

    Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

    CARDINAL HEALTHCARE

    Lots, distribution and details
    Product
    Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg), 18 Tablets per cartons, Distributed By Cardinal Health, Dublin, Ohio 43017. NDC: 70000-0126-1
    Lots / codes
    Batch P125514
    Distribution
    Nationwide USA
    Quantity
    1 unit
    Recall started
    January 26, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0186-2024
  • Class II Terminated

    Jardiance (empagliflozin tablets), 25 mg, 30 tablets (3 blister cards with 10 tablets each), Rx only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877. NDC: 0597-0153-37

    Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

    CARDINAL HEALTHCARE · Empagliflozin

    Lots, distribution and details
    Product
    Jardiance (empagliflozin tablets), 25 mg, 30 tablets (3 blister cards with 10 tablets each), Rx only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877. NDC: 0597-0153-37
    Lots / codes
    Batch D41919
    Distribution
    Nationwide USA
    Quantity
    1 unit
    Recall started
    January 26, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0185-2024

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 4, 2026 02:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.

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