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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 Terminated Historical recordClass II

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

by Hikma Injectables USA Inc

Reason: Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Recall initiated: December 19, 2024
Reported by FDA: January 8, 2025
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

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

by VIONA PHARMACEUTICALS INC

Reason: Crystallization
Recall initiated: December 10, 2024
Reported by FDA: January 8, 2025
Distribution: US Nationwide

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Drug Recall Ongoing Historical recordClass II

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

by VIONA PHARMACEUTICALS INC

Reason: Crystallization
Recall initiated: December 10, 2024
Reported by FDA: January 8, 2025
Distribution: US Nationwide

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Drug Recall Ongoing Historical recordClass I

FORCE FOREVER 400mg Tablets, Huesos y articulaciones sin dolor, SUPLEMENTO ALIMENTICIO, 60-count bottles

by GNMart LLC

Reason: Marketed without an approved NDA/ANDA. FDA analysis found the product to be tainted with Diclofenac and Dexamethasone.
Recall initiated: December 12, 2024
Reported by FDA: January 8, 2025
Distribution: Nationwide within the United States

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Drug Recall Terminated Historical recordClass III

Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC 70069-716-01

by SOMERSET THERAPEUTICS LLC

Reason: Failed Impurities/Degradation Specifications
Recall initiated: December 16, 2024
Reported by FDA: January 8, 2025
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass II

Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478. NDC#: 50268-625-15.

by AvKARE

Reason: Failed Dissolution Specifications
Recall initiated: December 4, 2024
Reported by FDA: January 8, 2025
Distribution: Nationwide USA

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Drug Recall Terminated Historical recordClass II

Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited, Pithampur (M.P)- 454 775 INDIA, NDC# 68180-967-03

by Lupin Pharmaceuticals Inc.

Reason: Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.
Recall initiated: December 20, 2024
Reported by FDA: January 8, 2025
Distribution: One US distributor in Ohio.

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Drug Recall Ongoing Historical recordClass II

UMARY ACID HYALURONIC, 850 MG CAPLETS, 30-count bottle, UPC7502265120323

by MXBBB

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.
Recall initiated: November 14, 2024
Reported by FDA: January 1, 2025
Distribution: Product was sold via Amazon Marketplace.

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Drug Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged by: RemedyRepack Inc., Indiana, PA

by RemedyRePack Inc.

Reason: CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
Recall initiated: December 2, 2024
Reported by FDA: January 1, 2025
Distribution: Nationwide in the US

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Drug Recall Terminated Historical recordClass II

Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit contains: 30 sterile and non-pyrogenic reaction vials each containing Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetratluoroborate - 1 mg; Stannous Chloride Dihydrate - 0.D75 mg; L-Cysteine Hydrochloride Monohydrate - 1 mg; Sodium Citrate Dihydrate - 2.6 mg; Mannitol - 20 mg. The pH is adjusted to 5.6 to 5.7 with HCI or NaOH prior to lyophilization. Sealed under nitrogen. 30 Radioassay Information Labels with radiation warning symbol. 1 package insert, Rx only, Manufacture by: Curium US LLC, Maryland Heights, MO 63043, 69945-092-40

by Curium US, LLC

Reason: Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
Recall initiated: November 26, 2024
Reported by FDA: January 1, 2025
Distribution: Nationwide USA and Canada.

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Drug Recall Terminated Historical recordClass II

DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90

by PD-Rx Pharmaceuticals, Inc.

Reason: CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit
Recall initiated: December 4, 2024
Reported by FDA: January 1, 2025
Distribution: Distributed within US: FL, MS, WI

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Drug Recall Ongoing Historical recordClass II

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

by Breckenridge Pharmaceutical, Inc

Reason: CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Recall initiated: December 6, 2024
Reported by FDA: January 1, 2025
Distribution: Nationwide in the US

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Drug Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.

by Breckenridge Pharmaceutical, Inc

Reason: CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Recall initiated: December 6, 2024
Reported by FDA: January 1, 2025
Distribution: Nationwide in the US

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Drug Recall Ongoing Historical recordClass II

chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-862-01

by Glenmark Pharmaceuticals Inc., USA

Reason: CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Recall initiated: December 11, 2024
Reported by FDA: January 1, 2025
Distribution: USA Nationwide

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Drug Recall Ongoing Historical recordClass II

chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-861-01

by Glenmark Pharmaceuticals Inc., USA

Reason: CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Recall initiated: December 11, 2024
Reported by FDA: January 1, 2025
Distribution: USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08

by Amerisource Health Services LLC

Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Recall initiated: December 6, 2024
Reported by FDA: January 1, 2025
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules USP, 60 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-04

by Amerisource Health Services LLC

Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Recall initiated: December 6, 2024
Reported by FDA: January 1, 2025
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, 90 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-05

by Amerisource Health Services LLC

Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Recall initiated: December 6, 2024
Reported by FDA: January 1, 2025
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-04

by Amerisource Health Services LLC

Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Recall initiated: December 6, 2024
Reported by FDA: January 1, 2025
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured for: Macleods Pharma USA Inc. Princeton, NJ,08540: Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi Himachal Pradesh, INDIA, NDC 33342-067-07.

by Macleods Pharmaceuticals Ltd

Reason: Failed Impurities/Degradation Specifications
Recall initiated: November 25, 2024
Reported by FDA: December 25, 2024
Distribution: Nationwide in the USA

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Data last updated: October 31, 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.