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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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Drug Recall Ongoing Historical recordClass II

Semaglutide Injection, 8mg/3.2mL (2.5 mg/mL), 3.2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-09

by ProRx LLC

Reason: Lack of Assurance of Sterility
Recall initiated: October 15, 2025
Reported by FDA: November 5, 2025
Distribution: TX and UT

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Drug Recall Ongoing Historical recordClass II

Semaglutide Injection, 6mg/2.4mL (2.5 mg/mL), 2.4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-08

by ProRx LLC

Reason: Lack of Assurance of Sterility
Recall initiated: October 15, 2025
Reported by FDA: November 5, 2025
Distribution: TX and UT

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Drug Recall Ongoing Historical recordClass II

Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-04

by ProRx LLC

Reason: Lack of Assurance of Sterility
Recall initiated: October 15, 2025
Reported by FDA: November 5, 2025
Distribution: TX and UT

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Drug Recall Ongoing Historical recordClass II

Semaglutide Injection, 12.5/5mL (2.5 mg/mL), 5mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-09

by ProRx LLC

Reason: Lack of Assurance of Sterility
Recall initiated: October 15, 2025
Reported by FDA: November 5, 2025
Distribution: TX and UT

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Drug Recall Ongoing Historical recordClass II

R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Tromethamine) in Sodium Chloride Solution, Total Volume: 50 mL syringe. INJECTION FOR PERIARTICULAR USE; Not for IV Use. THIS IS A COMPOUNDED DRUG. QuVA Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, TX 77478. NDC 70092-1433-50

by QuVa Pharma, Inc.

Reason: Presence of Particulate Matter
Recall initiated: October 10, 2025
Reported by FDA: November 5, 2025
Distribution: U.S. Nationwide

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Drug Recall Ongoing Historical recordClass II

Desipramine Hydrochloride Tablets, USP, 150 mg, 50 count bottle (NDC 23155-583-25), 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.

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Drug Recall Ongoing Historical recordClass II

Desipramine Hydrochloride Tablets, USP, 100 mg, 100 count bottle (NDC 23155-582-01), 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.

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Drug Recall Ongoing Historical recordClass II

Desipramine Hydrochloride Tablets, USP, 50 mg, 100 count bottle (NDC 23155-580-01), 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.

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Drug Recall Ongoing Historical recordClass II

Desipramine Hydrochloride Tablets, USP, 25 mg, 100 count bottle (NDC 23155-579-01), 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.

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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.

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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

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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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Data last updated: October 30, 2026 ET

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.