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.
1,094 recalls
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Class I Ongoing
Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan, Distributed by: Astellas Pharma US, Inc., Northbrook, IL 60062, NDC 0469-0607-73.
Reason: Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Lots, distribution and details
- Lots / codes
- Lot# 0E3353D, Exp 03/31/2026
- Distribution
- Nationwide in the USA
- Quantity
- 14,340 100-count bottles
- Recall started
- December 23, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0211-2025
-
Class I Ongoing
Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of Japan, Distributed by: Astellas Pharma US Inc., Northbrook, IL 60062, NDC 0469-0647-73.
Reason: Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Lots, distribution and details
- Lots / codes
- Lot# 0R3092A, EXP 03/31/2026
- Distribution
- Nationwide in the USA
- Quantity
- 3,500 30-count bottles
- Recall started
- December 23, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0210-2025
-
Class I Ongoing
FOUZEE SugarLin HERBAL FORMULA capsules, 180 capsules per bottle, Sold and Distributed by Shoppers-Plaza, Hawthorne, CA 90250. Product of India. UPC 8 26656 69047 7
Reason: Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and glyburide
Lots, distribution and details
- Lots / codes
- Batch # 001, exp. date 09/10/2026
- Distribution
- Nationwide via internet sales
- Quantity
- 172 180-count bottles
- Recall started
- December 16, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0207-2025
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Class II Ongoing
First Aid Beauty Ultra Repair Cream, colloidal oatmeal 0.5%, Coconut Vanilla, Net Wt. 396.8 g (14 OZ), DISTR. BY: First Aid Beauty LTD, Newton, MA, 02458, UPC 8 15517 02955 6
Reason: CGMP Deviations; product intended for quarantine was inadvertently distributed
Lots, distribution and details
- Lots / codes
- Lots 24D44, Exp 4/10/2026 & 24D45, 4/11/2026
- Distribution
- Nationwide
- Quantity
- 2756 jars
- Recall started
- December 23, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0206-2025
-
Class II Terminated
Cardura XL (doxazosin) extended release tablets 4 mg, 30 -count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-078-93
Reason: Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Lots, distribution and details
- Lots / codes
- Lot# 8182298, Exp 10/31/2025
- Distribution
- USA nationwide.
- Quantity
- 6,605/30 count bottles
- Recall started
- December 23, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0204-2025
-
Class II Terminated
Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-079-93
Reason: Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Lots, distribution and details
- Lots / codes
- Lot # 8181625, Exp 12/31/2025
- Distribution
- USA nationwide.
- Quantity
- 1,215/30 count bottles
- Recall started
- December 23, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0203-2025
-
Class II Terminated
glipiZIDE, Extended-Release Tablets, 2.5 mg, 30-count (3×10 blister cards) carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC: 60687-480-21, Unit Dose NDC: 60687-480-11
Reason: Failed Dissolution Specifications:
Lots, distribution and details
- Lots / codes
- Lot # 1012910, Exp Date: 04/30/2025
- Distribution
- Nationwide in the USA
- Quantity
- 2,028 units (cartons of 30 individual unit doses)
- Recall started
- December 17, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0202-2025
-
Class II Ongoing
Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3×10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-423-11
Reason: Presence of Foreign Tablets/Capsules
Lots, distribution and details
- Lots / codes
- Lot #: 1018598, Exp. Date 10/31/2025
- Distribution
- Nationwide within the United States
- Quantity
- 4640 units
- Recall started
- January 7, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0201-2025
-
Class II Ongoing
Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles; Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ
Reason: CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Lots, distribution and details
- Product
- Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles; Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ
- Lots / codes
- Lot # a) DT6023053A, DT6023061A, DT6023068A, DT6023074A, exp. date Jan-25; DT6023078A, DT6023076A, exp. date Feb-25; DTC24043A, DTC24044A, exp. date Dec-25 b) DT6023002A, DT6023016A, DT6023036A, exp. date Dec-24; DT6023048A, exp. date Jan-25
- Distribution
- Nationwide
- Quantity
- 244,460 bottles
- Recall started
- December 30, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0190-2025
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Class II Ongoing
Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ NDC 57237-017-60
Reason: CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Lots, distribution and details
- Lots / codes
- Lot # DT2023003A, DT2023007A, DT2023008A, exp. date Jan-25
- Distribution
- Nationwide
- Quantity
- 73,680 bottles
- Recall started
- December 30, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0189-2025
-
Class II Ongoing
Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ
Reason: CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Lots, distribution and details
- Lots / codes
- a) Lot# DT3023051A, exp. date Apr-25; b) DT3023025A, exp. date Jan-25
- Distribution
- Nationwide
- Quantity
- 42,527 bottles
- Recall started
- December 30, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0188-2025
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Class II Ongoing
medroxyPROGESTERone Acetate Injectable Suspension, USP, 150mg per mL, Rx only, 1 mL Single-Dose Vial, Mfd in India for: Eugia US LLC, NJ 08520 NDC 55150-329-01 Shipper label: medroxyPROGESTERone Acetate Injectable Suspen…
Reason: CGMP Deviations
Lots, distribution and details
- Product
- medroxyPROGESTERone Acetate Injectable Suspension, USP, 150mg per mL, Rx only, 1 mL Single-Dose Vial, Mfd in India for: Eugia US LLC, NJ 08520 NDC 55150-329-01 Shipper label: medroxyPROGESTERone Acetate Injectable Suspension, USP, 150 mg per mL, Distributed by: Eugia US LLC, NJ, Manufactured by: Eugia Pharma Specialties Limited, India
- Lots / codes
- Lot No.: 1MP24069, Exp.: 08/2026
- Distribution
- Nationwide in the US
- Quantity
- 19872 vials
- Recall started
- December 18, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0185-2025
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Class II Ongoing
Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3×10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-423-21
Reason: Presence of Foreign Tablets/Capsules
Lots, distribution and details
- Lots / codes
- Lot #: 1019594, Exp. Date 12/31/2025
- Distribution
- Nationwide within the United States
- Quantity
- 5,178 cartons
- Recall started
- December 13, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0184-2025
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Class III Ongoing
Methadone Hydrochloride Tablets, USP, 5mg, 10×10 Unit-Dose Tablets, Rx Only, Distributed by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0709-20
Reason: Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
Lots, distribution and details
- Lots / codes
- Lot # AC2556A; Exp. 03/2027
- Distribution
- US Nationwide.
- Quantity
- 2591 100-count boxes
- Recall started
- December 19, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0183-2025
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Class II Ongoing
Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India, NDC 69315-308-05
Reason: Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Lots, distribution and details
- Lots / codes
- Lot: 083L111, Exp. 11/30/2025; 084A032, Exp. 12/31/2025
- Distribution
- Nationwide
- Quantity
- 136,181 bottles
- Recall started
- December 16, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0182-2025
-
Class I Ongoing
Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-309-02 (ca…
Reason: Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Lots, distribution and details
- Product
- Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-309-02 (carton), NDC #: 49884-309-52 (blisters).
- Lots / codes
- Lot #s: 550145201, Exp. 08/31/2026; 550175901, 550176001, 550176201, Exp. 02/28/2027
- Distribution
- Nationwide in the USA
- Quantity
- 22,513 cartons
- Recall started
- November 18, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0181-2025
-
Class I Ongoing
Clonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-307-02…
Reason: Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Lots, distribution and details
- Product
- Clonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-307-02 (carton), NDC #: 49884-307-52 (blisters).
- Lots / codes
- Lot #s: 550142801, 550142901, 550143001, 550143101, 550143201, 550143301, 550143401, 550147201, 550147401, Exp. 08/31/2026.
- Distribution
- Nationwide in the USA
- Quantity
- 72,973 cartons
- Recall started
- November 18, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0180-2025
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Class I Ongoing
Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-306-02…
Reason: Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Lots, distribution and details
- Product
- Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-306-02 (carton), NDC #: 49884-306-52 (blisters).
- Lots / codes
- Lot #: 550174101, Exp. 01/31/2027.
- Distribution
- Nationwide in the USA
- Quantity
- 8,029 cartons
- Recall started
- November 18, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0179-2025
-
Class I Ongoing
Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV, Rx Only, 60 Tablets per carton, 10 blister cards containing 6 tablets each, Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-310-02 (cart…
Reason: Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Lots, distribution and details
- Product
- Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV, Rx Only, 60 Tablets per carton, 10 blister cards containing 6 tablets each, Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-310-02 (carton), NDC#: 49884-310-52 (blisters).
- Lots / codes
- Lot # 550176501, 550176601, Exp 02/28/2027.
- Distribution
- Nationwide in the USA
- Quantity
- 9,816 cartons
- Recall started
- November 18, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0178-2025
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Class III Ongoing
Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-678-15
Reason: LABELING: LABEL MIX-UP
Lots, distribution and details
- Lots / codes
- Lot #: 0160, Exp. Date April 26 2026
- Distribution
- Nationwide within the United States
- Quantity
- —
- Recall started
- December 18, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0176-2025
-
Class III Ongoing
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by: AvKARE, Pulaski, TN, 38478, NDC 50268-068-15.
Reason: LABELING: LABEL MIX-UP
Lots, distribution and details
- Lots / codes
- Lot #: 0160, Exp. Date April 26 2026
- Distribution
- Nationwide within the United States
- Quantity
- 16,677 cartons
- Recall started
- December 18, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0175-2025
-
Class II Ongoing
Dapsone Gel 7.5%, 90 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-03. packaged in an Airless pump pack
Reason: Crystallization
Lots, distribution and details
- Product
- Dapsone Gel 7.5%, 90 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-03. packaged in an Airless pump pack
- Lots / codes
- Lots T400514, Exp Date 02/2026 & T400808, Exp Date 03/2026
- Distribution
- US Nationwide
- Quantity
- 2760 packs
- Recall started
- December 10, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0172-2025
-
Class II Ongoing
Dapsone Gel 7.5%, 60 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahemedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02. packaged in an Airless pump pack
Reason: Crystallization
Lots, distribution and details
- Product
- Dapsone Gel 7.5%, 60 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahemedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02. packaged in an Airless pump pack
- Lots / codes
- Lots T400513, Exp Date 02/2026; T400807, Exp Date 03/2026; T401152, Exp Date 06/2026; T401303, Exp Date 07/2026; T401304, Exp Date 07/2026; T401399, Exp Date 07/2026 & T401696 Exp Date 08/2026.
- Distribution
- US Nationwide
- Quantity
- 23304 packs
- Recall started
- December 10, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0171-2025
-
Class II Ongoing
UMARY ACID HYALURONIC, 850 MG CAPLETS, 30-count bottle, UPC7502265120323
Reason: cGMP Deviations: the firm initiated a recall after notification from the distributor that product may be tainted with undeclared diclofenac and omeprazole, however there is no analytical data confirming that product distributed by the firm is tainted.
Lots, distribution and details
- Lots / codes
- Lot#: 24183, Exp 07/01/28
- Distribution
- Product was sold via Amazon Marketplace.
- Quantity
- 321 bottles
- Recall started
- November 14, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0166-2025
-
Class II Terminated
PROFESSIONAL Regener-Eyes, Ophthalmic Solution (glycerin 0.5%) , 3mL bottles, Distributed by: Regener-Eyes, Tampa, FL; Manufactured by: Regenerative Processing Plant, LLC, 34176 US HWY 19N, FL, NDC 82305-003-01
Reason: Lack of Sterility Assurance
Lots, distribution and details
- Lots / codes
- Lot #: P120522A, Exp. Date 12/5/2025, P120522B, Exp. Date 12/5/2024; P120822A, Exp. Date 12/8/2024; P1208228, Exp. Date 12/8/2024; P121222A, P1212228, Exp. Date 12/12/2024; P121922A, P121922B, Exp. Date 12/19/2024; P122222A, Exp. Date 12/22/2024; P122622A, P122622B, Exp. Date 12/26/2024; P010223A, Exp. Date 1/2/2025; P010423PV1, Exp. Date 1/4/2025; P010523A, P010523B, Exp. Date 1/5/2025; P010923A, Exp. Date 1/9/2025; P011123PV2, Exp. Date 1/11/2025; P011223A, P011223B, Exp. Date 1/12/2025; P011623A, Exp. Date 1/16/2025; P011823PV3, Exp. Date 1/18/2025; P011923A, P011923B, Exp. Date 1/19/2025; P012323A, P012323B, Exp. Date 1/23/2025; P012623A, Exp. Date 1/26/2025; P013023A, Exp. Date 1/30/2025; P020123A, Exp. Date 2/1 /2025; P020723A, Exp. Date 2/7/2025; P021423, Exp. Date 2/14/2025, P021623A, Exp. Date 2/16/2025; P022023A, Exp. Date 2/20/2025; P022223A, Exp. Date 2/22/2025; P022823A, Exp. Date 2/28/2025; P030123A, Exp. Date 3/1/2025; P050423A, Exp. Date 5/4/2025, P051823A, Exp. Date 5/18/2025, P052523A, Exp. Date 5/25/2025
- Distribution
- Nationwide within the United States
- Quantity
- 59275
- Recall started
- December 10, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0153-2025
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 3, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.