All recall categories

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 May 15, 2024

Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles (NDC 51991-747-90), (b) 1000-count…

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

Breckenridge Pharmaceutical, Inc.

2 more products in this recall

FDA (openFDA drug enforcement)

Drugs

Reported May 15, 2024

Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only,…

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

Dr. Reddy's Laboratories, Inc.

1 more product in this recall

FDA (openFDA drug enforcement)

Drugs

Reported May 15, 2024

Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles…

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

FDC Limited

FDA (openFDA drug enforcement)

Drugs

Reported May 15, 2024

TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3824-00; (b) 90-count blister pack, NDC…

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

RemedyRepack Inc.

FDA (openFDA drug enforcement)

Drugs

Reported May 15, 2024

traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distributed by: Advagen Pharma Limited, 666…

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

Rubicon Research Private Limited

FDA (openFDA drug enforcement)

Drugs

Reported May 15, 2024

Amphotericin B Liposome for Injection, 50mg vials, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.…

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

Sun Pharmaceutical Industries Inc.

FDA (openFDA drug enforcement)

Drugs

Reported May 8, 2024

Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC,…

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

Amneal Pharmaceuticals

FDA (openFDA drug enforcement)

Drugs

Reported May 8, 2024

Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by:…

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

Hikma Injectables USA Inc.

FDA (openFDA drug enforcement)

Drugs

Reported May 8, 2024

Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution 1%, 0.5%, 0.075%, 8mL, Compounded By:…

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

Imprimis NJOF, LLC

1 more product in this recall

FDA (openFDA drug enforcement)

Drugs

Reported May 8, 2024

EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Syringe, Rx only,…

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

Regeneron Pharmaceuticals Inc.

FDA (openFDA drug enforcement)

Drugs

Reported May 8, 2024

Valacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown,…

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

Viatris Inc.

FDA (openFDA drug enforcement)

Drugs

Reported May 1, 2024

Alcoholada Gel, Pain Relieving Gel, 0.5% Lidocaine Hydrochloride, packaged in (a) 8.5 fl oz (251 mL) plastic bottle UPC…

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

Aruba Aloe Balm N.V.

1 more product in this recall

FDA (openFDA drug enforcement)

Drugs

Reported May 1, 2024

Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton…

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

Cipla USA, Inc.

FDA (openFDA drug enforcement)

Drugs

Reported May 1, 2024

Cloderm (clocortolone pivalate) Cream, 0.1%, Rx Only, For Topical Use Only, Net Wt 45g, Manufactured for: EPI Health,…

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

EPI Health, LLC

2 more products in this recall

FDA (openFDA drug enforcement)

Drugs

Reported May 1, 2024

ForeverMen Natural Energy Boost Capsules, packaged in a box containing a 10-count blister card.

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

FA Online Inc.

FDA (openFDA drug enforcement)

Drugs

Reported May 1, 2024

Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only,…

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

Glenmark Pharmaceuticals Inc., USA

FDA (openFDA drug enforcement)

Drugs

Reported May 1, 2024

Eyesaline, Saline Eyewash Solution, Cartridge for Fendall 2000, Net contents: 7.9 gal per cartridge, Sperian Eye & Face…

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

Honeywell Inc.

FDA (openFDA drug enforcement)

Drugs

Reported May 1, 2024

GloStrips, Fluorescein Sodium Ophthalmic Strips USP (0.6 mg Fluorescein), Rx Only, a) 100 strips per carton, NDC…

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

Nomax Inc.

3 more products in this recall

FDA (openFDA drug enforcement)

Drugs

Reported May 1, 2024

Spanish Fly 22K capsules, 2-count box, UPC 0 664979 979455

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

Pyramids Wholesale Inc.

10 more products in this recall

FDA (openFDA drug enforcement)

Drugs

Reported May 1, 2024

Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC…

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

Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.

3 more products in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Apr 24, 2024

Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3; (b)…

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

Amneal Pharmaceuticals

FDA (openFDA drug enforcement)

Drugs

Reported Apr 24, 2024

Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cartons, Rx Only, Manufactured for: AvKARE,…

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

AvKARE

FDA (openFDA drug enforcement)

Drugs

Reported Apr 24, 2024

Sterile Diluent, HUMALOG U-100 (insulin lispro injection), HUMULIN R U-100 REGULAR (insulin human injection), Insulin…

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

Eli Lilly & Company

FDA (openFDA drug enforcement)

Drugs

Reported Apr 24, 2024

NEXLIZET (bempedoic acid and ezetimibe) tablets, 180 mg/10 mg, 30-count bottle, Rx only, Manufactured for: Esperion…

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

Esperion

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.