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Prescription and over-the-counter medication recalls

Drug recalls come from the FDA's drug enforcement reports. They range from a wrong label to a product that could be harmful, and the risk level on each notice is the FDA's own classification. Never stop a prescribed medication on the strength of a recall notice alone — the notice will say whether to return it, and your prescriber or pharmacist decides what replaces it.

4,474 stored notices, reported between Jun 20, 2012 and Sep 9, 2026. Newest first.

Drugs

Reported Jan 15, 2025

Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection, 10 mL Multi-Dose Reaction Vial, 5 vial Box, Rx…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Jubilant Draximage Inc., dba Jubilant Radiopharma

FDA (openFDA drug enforcement)

Drugs

Reported Jan 15, 2025

Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99)…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Rising Pharma Holding, Inc.

2 more products in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Jan 15, 2025

Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets, Rx Only, Distributed by: Hikma Pharmaceuticals USA…

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

West-Ward Columbus Inc.

FDA (openFDA drug enforcement)

Drugs

Reported Jan 8, 2025

Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE,…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

AvKARE

2 more products in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Jan 8, 2025

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

High riskUsing this product could cause serious injury, illness or death — stop using it now.

GNMart LLC

FDA (openFDA drug enforcement)

Drugs

Reported Jan 8, 2025

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…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Hikma Injectables USA Inc.

1 more product in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Jan 8, 2025

Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: Lupin Pharmaceuticals,…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Lupin Pharmaceuticals Inc.

FDA (openFDA drug enforcement)

Drugs

Reported Jan 8, 2025

Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC.…

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

Somerset Therapeutics LLC

FDA (openFDA drug enforcement)

Drugs

Reported Jan 8, 2025

Dapsone Gel 7.5%, 60 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahemedabad, India, Distributed by: Viona…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Viona Pharmaceuticals Inc.

1 more product in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Jan 1, 2025

Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited,…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Amerisource Health Services LLC

3 more products in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Jan 1, 2025

Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Breckenridge Pharmaceutical, Inc.

1 more product in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Jan 1, 2025

Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit contains: 30 sterile and non-pyrogenic…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Curium US, LLC

FDA (openFDA drug enforcement)

Drugs

Reported Jan 1, 2025

chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Glenmark Pharmaceuticals Inc., USA

1 more product in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Jan 1, 2025

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

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Mxbbb

FDA (openFDA drug enforcement)

Drugs

Reported Jan 1, 2025

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

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

PD-Rx Pharmaceuticals, Inc.

FDA (openFDA drug enforcement)

Drugs

Reported Jan 1, 2025

Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

RemedyRepack Inc.

FDA (openFDA drug enforcement)

Drugs

Reported Dec 25, 2024

VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators, Net Wt. 0.09 oz (2.55g) Each, Distributed By:…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Apothecus Pharmaceutical Corp.

FDA (openFDA drug enforcement)

Drugs

Reported Dec 25, 2024

Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Aurobindo Pharma USA Inc.

FDA (openFDA drug enforcement)

Drugs

Reported Dec 25, 2024

Gelato, Benzocaine 20% Topical Gel Anesthetic Gel, Net Wt. 1 oz. (30ml), Manufactured by Keystone Industries 480 S.…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Keystone Industries

11 more products in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Dec 25, 2024

Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Macleods Pharmaceuticals Ltd.

FDA (openFDA drug enforcement)

Drugs

Reported Dec 25, 2024

Dihydroergotamine Mesylate Injection, solution for injection, USP, 1 mg/mL Ampules, Rx Only, Distributed by: Provepharm…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Provepharm Inc.

FDA (openFDA drug enforcement)

Drugs

Reported Dec 25, 2024

LITE Regener-Eyes, Ophthalmic Solution (glycerin 0.4%), 3mL bottles, Distributed by: Regener-Eyes, Tampa, FL;…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Regenerative Processing Plant, LLC

1 more product in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Dec 18, 2024

Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA,…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Ascend Laboratories, LLC

1 more product in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Dec 18, 2024

Varithena (polidocanol injectable foam) Administration Pack, Contains: 3 silicone-free syringes, 2 compression pads, 1…

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

Biocompatibles UK, Ltd.

FDA (openFDA drug enforcement)

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RecallNow is not a government agency. Every notice above was published by the FDA, USDA FSIS or CPSC and links back to its source. Browse the whole archive.