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
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Class III Ongoing
Diphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8028-1.
Reason: Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Lots, distribution and details
- Lots / codes
- Lot: KDC0124001A Exp 09/30/2026.
- Distribution
- Nationwide in the US
- Quantity
- 7198 bottles
- Recall started
- December 12, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0197-2025
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Class III Ongoing
Acetaminophen Extra Strength 500 mg, 1000 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., 373 US RT 46 W Building E, Suite 117, Fairfield, NJ 07034, NDC 71399-8022-02
Reason: Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Lots, distribution and details
- Product
- Acetaminophen Extra Strength 500 mg, 1000 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., 373 US RT 46 W Building E, Suite 117, Fairfield, NJ 07034, NDC 71399-8022-02
- Lots / codes
- Lot #s: KDT0224001B, Exp 08/31/2026; KDT0224002B, Exp 09/30/2026.
- Distribution
- Nationwide in the US
- Quantity
- 1232 bottles
- Recall started
- December 12, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0196-2025
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Class III Ongoing
Acetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., Fairfield, NJ 07034, NDC 71399-8014-01.
Reason: Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Lots, distribution and details
- Lots / codes
- Lot #s: KDT0124004, KDT0124005, KDT0124006, Exp 08/31/2026
- Distribution
- Nationwide in the US
- Quantity
- 14825 bottles
- Recall started
- December 12, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0195-2025
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Class III Ongoing
Acetaminophen Regular Strength, 325 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8024-01 .
Reason: Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Lots, distribution and details
- Lots / codes
- Lot #: KDT0124001, Exp 08/31/2026
- Distribution
- Nationwide in the US
- Quantity
- 6429 bottles
- Recall started
- December 12, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0194-2025
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Class III Ongoing
Acetaminophen Extra Strength 500 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8022-01.
Reason: Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Lots, distribution and details
- Lots / codes
- Lot: KDT0224002A, Exp 09/30/2026
- Distribution
- Nationwide in the US
- Quantity
- 768 bottles
- Recall started
- December 12, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0193-2025
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Class II Terminated
Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules India Limited, Hyderabad- 500 081, India, Manufactured for: Quallent Pharmaceuticals Health LLC, Grand…
Reason: Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.
Lots, distribution and details
- Product
- Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules India Limited, Hyderabad- 500 081, India, Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Grand Cayman Islands, NDC 82009-117-10
- Lots / codes
- Lot #: 4911311A, Exp. Date: 11/2025
- Distribution
- Distributor in OH.
- Quantity
- 6,804 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-0192-2025
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Class II Ongoing
Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection, 10 mL Multi-Dose Reaction Vial, 5 vial Box, Rx Only, Manufactured for: Jubilant Draximage Inc., dba Jubilant Radiopharma, Kirkland , Quebec, H9H, 4J$…
Reason: Failed Stability Specifications
Lots, distribution and details
- Product
- Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection, 10 mL Multi-Dose Reaction Vial, 5 vial Box, Rx Only, Manufactured for: Jubilant Draximage Inc., dba Jubilant Radiopharma, Kirkland , Quebec, H9H, 4J$, Canada, NDC# 65174-179-05.
- Lots / codes
- LOT C2300070 and C2300070E;Exp. May 31, 2025
- Distribution
- US Nationwide.
- Quantity
- 5209 kits
- Recall started
- November 22, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0191-2025
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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
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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 Terminated
Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03
Reason: Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.
Lots, distribution and details
- Lots / codes
- Lot#: GPC240763B, Exp. Date 6/17/2026
- Distribution
- Nationwide within the United States
- Quantity
- 96 Bottles
- 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-0187-2025
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Class II Ongoing
Progesterone Injection USP, 500mg per 10 mL (50mg/mL), 10 mL Multiple Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC. E. Windsor NJ 08520 NDC # 55150-306-10
Reason: Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Lots, distribution and details
- Product
- Progesterone Injection USP, 500mg per 10 mL (50mg/mL), 10 mL Multiple Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC. E. Windsor NJ 08520 NDC # 55150-306-10
- Lots / codes
- Batch # 1PR24010, Expiry: 02/28/2027
- Distribution
- Distributed Nationwide in the USA.
- Quantity
- 17,300 10-mL vials
- Recall started
- December 27, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0186-2025
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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
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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
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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
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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 I Ongoing
Nhan Sam Tuyet Lien Truy Phong Hoan, Capsules, 30-Count Bottles, Manufactured by Yee Hong Pharmaceuticals, SDN, Penang, Malasia.
Reason: Marketed without an Approved NDA/ANDA: FDA analysis found the products to be tainted with undeclared Furosemide, Dexamethasone and Chlorpheniramine
Lots, distribution and details
- Lots / codes
- All codes, unknown expiration dates all before 05/2030.
- Distribution
- U.S Nationwide.
- Quantity
- 26 bottles
- Recall started
- December 12, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0177-2025
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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
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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
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Class II Terminated
phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, NDC 63037-173-25
Reason: Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Lots, distribution and details
- Lots / codes
- Lot number: 243120003D, Use by Date: 03/11/2025
- Distribution
- Nationwide in the USA
- Quantity
- —
- Recall started
- December 19, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0174-2025
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Class II Terminated
ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, For IV or IM Use, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, This is a Compounded Drug. Hospital/Office Use Only. NDC 63037-…
Reason: Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Lots, distribution and details
- Product
- ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, For IV or IM Use, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, This is a Compounded Drug. Hospital/Office Use Only. NDC 63037-137-25
- Lots / codes
- Lot number: 242560008D, Use by Date 01/15/2025; 242970002D, Use by Date 02/25/2025
- Distribution
- Nationwide in the USA
- Quantity
- 1,800 syringes
- Recall started
- December 19, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0173-2025
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 02:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.