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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Showing 661–680 of 17,898 drug recalls

Drug Recall Ongoing Historical recordClass II

Desipramine Hydrochloride Tablets, USP, 10 mg, 100 - count bottle (NDC 23155-578-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.

by Heritage Pharmaceuticals Inc

Reason
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Recall initiated
October 6, 2025
Reported by FDA
November 5, 2025
Distribution
U.S. Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

Prazosin Hydrochloride, Capsules, USP, 5 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4069-01, b) 250 Capsules, NDC 0093-4069-52, c) 500 Capsules, NDC 0093-4069-05

by Teva Pharmaceuticals USA, Inc

Reason
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Recall initiated
October 7, 2025
Reported by FDA
November 5, 2025
Distribution
U.S. Nationwide

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Drug Recall Ongoing Historical recordClass II

Prazosin Hydrochloride, Capsules, USP, 2 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4068-01, b) 1000 Capsules, NDC 0093-4068-10

by Teva Pharmaceuticals USA, Inc

Reason
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Recall initiated
October 7, 2025
Reported by FDA
November 5, 2025
Distribution
U.S. Nationwide

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Drug Recall Ongoing Historical recordClass II

Prazosin Hydrochloride, Capsules, USP, 1 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4067-01, b) 1000 Capsules, NDC 0093-4067-10

by Teva Pharmaceuticals USA, Inc

Reason
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Recall initiated
October 7, 2025
Reported by FDA
November 5, 2025
Distribution
U.S. Nationwide

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Drug Recall Ongoing Historical recordClass II

Prazosin Hydrochloride, Capsules, USP, 5 mg, 20 capsules (5x4) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, carton NDC 60687-572-32, Individual unit dose: NDC 60687-572-33

by Amerisource Health Services LLC

Reason
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Recall initiated
October 16, 2025
Reported by FDA
November 5, 2025
Distribution
Nationwide within the United States

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Drug Recall Ongoing Historical recordClass II

Prazosin Hydrochloride, Capsules, USP, 2 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-997-01, Individual unit dose: NDC 68084-997-11

by Amerisource Health Services LLC

Reason
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Recall initiated
October 16, 2025
Reported by FDA
November 5, 2025
Distribution
Nationwide within the United States

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Drug Recall Ongoing Historical recordClass II

Prazosin Hydrochloride, Capsules, USP, 1 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-996-01. Individual unit dose: NDC 68084-996-11

by Amerisource Health Services LLC

Reason
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Recall initiated
October 16, 2025
Reported by FDA
November 5, 2025
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC 51991-748-10),Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain; Dist. by: Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ 07922.

by Breckenridge Pharmaceutical, Inc.

Reason
CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
Recall initiated
October 9, 2025
Reported by FDA
November 5, 2025
Distribution
U.S. Nationwide

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Drug Recall Ongoing Historical recordClass II

HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per carton, Rx only, Manufactured for: Organon LLC, a subsidiary of ORGANON & Co, Jersey City, NJ 07302, Manufactured by: SAMSUN BIOEPIS Co., Ltd, Incheon, Republic of Korea, NDC 78206-183-01.

by Samsung Bioepis Co., Ltd.

Reason
Lack of Assurance of Sterility.
Recall initiated
October 10, 2025
Reported by FDA
November 5, 2025
Distribution
Distributed only to one warehouse in NJ. with no further distribution

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Drug Recall Ongoing Historical recordClass II

Taoscare Motion Sickness Patches 36-count box, Henan Xinyongtal Medical Technology., Ltd., Address: he nan sheng zhou kou shi huai yang xian gong ye yuan qu, X003SR097N

by ibspot

Reason
Marketed Without an Approved NDA/ANDA
Recall initiated
October 9, 2025
Reported by FDA
October 29, 2025
Distribution
WY and VA

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Drug Recall Ongoing Historical recordClass II

Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/20 mL (12mg and 4mg/mL),Single Dose Vial, RX Only, Bristol-Myers Squibb Company, Princeton, NJ 08543, NDC 0003-7125-11

by Bristol-Myers Squibb Company

Reason
Lack of Assurance of Sterility.
Recall initiated
October 21, 2025
Reported by FDA
October 29, 2025
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Niacin Extended-release Tablets, USP, 1,000 mg, Rx Only, 90 Tablets per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC: 62175-322-46

by Lannett Company Inc.

Reason
Failed Dissolution Specifications
Recall initiated
October 10, 2025
Reported by FDA
October 29, 2025
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

ZICAM" MEDICATED FRUIT DROPS ELDERBERRY FLAVOR, 25-drops per bottle, Distributed by: Church & Dwight Co., Inc. Ewing, NJ 08628, NDC 10237-469-25

by Church & Dwight Co., Inc.

Reason
Labeling: Label Mix-up: The product in the bottle contains elderberry and the label failed to indicate the inclusion of elderberry as an ingredient.
Recall initiated
October 1, 2025
Reported by FDA
October 29, 2025
Distribution
Product was distributed nationwide within the United States

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Drug Recall Ongoing Historical recordClass II

Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceuticals Private Limited, Sangareddy, Telangana, India, Dist. by: Rising Phar, NDC 16571-863-03.

by Graviti Pharmaceuticals Private Limited

Reason
Failed Tablet/Capsule Specifications
Recall initiated
September 15, 2025
Reported by FDA
October 29, 2025
Distribution
Product was distributed to 1 distributor and 16 wholesalers/pharmacy retailers nationwide.

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Drug Recall Ongoing Historical recordClass II

Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL Single-Dose Vial, For Intramuscular Use Only, Rx only, Mfd. for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Mfd. by: ASPIRO PHARMA LIMITED, Telangana - 502281, INDIA., U.S. Contact Number: 1-866-495-1995, NDC 31722-307-25 (Carton), 31722-307-02 (Vial label).

by Aspiro Pharma Limited

Reason
Presence of Particulate Matter: Particulate matter identified as glass
Recall initiated
October 1, 2025
Reported by FDA
October 29, 2025
Distribution
Nationwide within the United States

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Drug Recall Ongoing Historical recordClass II

Medline, Alcohol Prep Pads (2-Ply Pad, 70% Isopropyl Alcohol), 100 eaches per box, 10 boxes per case (1,000 eaches per case), Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL, 60093 USA, NDC 55329-811-30.

by Medline Industries, LP

Reason
Subpotent Drug
Recall initiated
September 29, 2025
Reported by FDA
October 29, 2025
Distribution
Nationwide within the United States

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Drug Recall Ongoing Historical recordClass II

Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %, 5 mL (0.17 FL OZ) bottles, Manufactured for: SOLA PHARMACEUTICALS LLC, Baton Rouge, LA 70810, NDC 70512-0520-05

by USV Private Limited

Reason
Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
Recall initiated
October 9, 2025
Reported by FDA
October 29, 2025
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing Historical recordClass III

Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-402-50

by JB Chemicals and Pharmaceuticals Ltd

Reason
Tablet/Capsules Imprinted with Wrong ID
Recall initiated
September 12, 2025
Reported by FDA
October 29, 2025
Distribution
U.S. Nationwide

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Drug Recall Ongoing Historical recordClass III

Cetirizine Hydrochloride Tablets USP 10 mg, 100 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-402-10.

by JB Chemicals and Pharmaceuticals Ltd

Reason
Tablet/Capsules Imprinted with Wrong ID
Recall initiated
September 12, 2025
Reported by FDA
October 29, 2025
Distribution
U.S. Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61 (Blister pack), NDC 55154-3363-0 (Outer Bag).

by The Harvard Drug Group LLC

Reason
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Recall initiated
October 10, 2025
Reported by FDA
October 29, 2025
Distribution
US Nationwide.

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Data last updated:

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.