FDA drug recalls
The latest medications recalled in the U.S., straight from the FDA's openFDA Enforcement database — what was recalled, why, and how serious it is. Informational only; for any product you have, follow the FDA's guidance and ask your pharmacist.
Subscribe to the recall feed (RSS) — every new recall as it lands, with the FDA's own stated reason.
Recalls by drug type
Mirabegron Extended-Release Tablets
Class IICGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Zydus Pharmaceuticals (USA) Inc · Aug 5, 2026
Dicyclomine Hydrochloride Capsules
Class IIshortfill; reports of empty capsules.
Aurobindo Pharma USA Inc · Jul 23, 2026
Azelaic Acid Gel
Class IICGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
Glenmark Pharmaceuticals Inc., USA · Jul 23, 2026
Dorzolamide HCl and Timolol Maleate Ophthalmic Solution
Class IIDefective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
MICRO LABS USA INC · Jul 22, 2026
Cyclophosphamide for Injection
Class IPresence of Particulate Matter; identified as stainless steel
Sunny Pharmtech Inc. · Jul 17, 2026
Cyclophosphamide for Injection
Class IPresence of Particulate Matter; identified as stainless steel
Sunny Pharmtech Inc. · Jul 17, 2026
Dabigatran Etexilate Capsules
Class IIIFailed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Ascend Laboratories, LLC · Jul 16, 2026
Total Parental Nutrition
Class IIIIncorrect Product Formulation
Central Admixture Pharmacy Services Inc · Jul 16, 2026
Dabigatran Etexilate Capsules
Class IIIFailed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Ascend Laboratories, LLC · Jul 16, 2026
Dabigatran Etexilate Capsules
Class IIIFailed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Ascend Laboratories, LLC · Jul 16, 2026
Glycopyrrolate Injection
Class IIPresence of Particulate Matter: Hair was found in product
Fresenius Kabi USA, LLC · Jul 16, 2026
Xylocaine (lidocaine HCl Injection
Class IIPresence of Particulate Matter: Hair was found in products
Fresenius Kabi USA, LLC · Jul 16, 2026
Lidocaine HCl Injection
Class IIPresence of Particulate Matter: Hair was found in products
Fresenius Kabi USA, LLC · Jul 16, 2026
Xylocaine (lidocaine HCl Injection
Class IIPresence of Particulate Matter: Hair was found in products
Fresenius Kabi USA, LLC · Jul 16, 2026
Naropin (ropivacaine hydrochloride Injection
Class IIPresence of Particulate Matter: Hair was found in products
Fresenius Kabi USA, LLC · Jul 16, 2026
Lidolog Kit, Kit Contains: Lidocaine HCl Injection, USP, 2% (2mL) vial, 1 Dose,…
Class IIILabeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Asclemed USA Inc. · Jul 15, 2026
Glycopyrrolate Oral Solution
Class IIFailed Impurities/Degradation Specifications
Precision Dose Inc. · Jul 14, 2026
Rohto Cooling Eye Drops Dry Aid (povidone 0.68%
Class IILack of Assurance of Sterility
Rohto-Mentholatum (Vietnam) Co., Ltd. · Jul 14, 2026
Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%
Class IILack of Assurance of Sterility
Rohto-Mentholatum (Vietnam) Co., Ltd. · Jul 14, 2026
Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%
Class IILack of Assurance of Sterility
Rohto-Mentholatum (Vietnam) Co., Ltd. · Jul 14, 2026
Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%
Class IILack of Assurance of Sterility
Rohto-Mentholatum (Vietnam) Co., Ltd. · Jul 14, 2026
Rohto Cooling Eye Drops Dry Aid (povidone 0.68%
Class IILack of Assurance of Sterility
Rohto-Mentholatum (Vietnam) Co., Ltd. · Jul 14, 2026
Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%
Class IILack of Assurance of Sterility
Rohto-Mentholatum (Vietnam) Co., Ltd. · Jul 14, 2026
Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%
Class IILack of Assurance of Sterility
Rohto-Mentholatum (Vietnam) Co., Ltd. · Jul 14, 2026
Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%
Class IILack of Assurance of Sterility
Rohto-Mentholatum (Vietnam) Co., Ltd. · Jul 14, 2026
Levothyroxine Sodium Tablets
Class IISubpotent Drug
Major Pharmaceuticals · Jul 13, 2026
Rising, Cyproheptadine Hydrochloride Syrup, 2mg/5 mL, 473 mL (ONE PINT), Rx only…
Class IIPresence of Precipitate: medication was crystallizing and particles floating in the bottle
Rising Pharma Holding, Inc. · Jul 13, 2026
Levothyroxine Sodium Tablets
Class IISubpotent Drug
Major Pharmaceuticals · Jul 13, 2026
Levothyroxine Sodium Tablets
Class IISubpotent Drug
Major Pharmaceuticals · Jul 13, 2026
Levothyroxine Sodium Tablets
Class IISubpotent Drug
Major Pharmaceuticals · Jul 13, 2026
Levothyroxine Sodium Tablets
Class IISubpotent Drug
Major Pharmaceuticals · Jul 13, 2026
Levothyroxine Sodium Tablets
Class IISubpotent Drug
Major Pharmaceuticals · Jul 13, 2026
Levothyroxine Sodium Tablets
Class IISubpotent Drug
Major Pharmaceuticals · Jul 13, 2026
Levothyroxine Sodium Tablets
Class IISubpotent Drug
Major Pharmaceuticals · Jul 13, 2026
Levothyroxine Sodium Tablets
Class IISubpotent Drug
Major Pharmaceuticals · Jul 13, 2026
Levothyroxine Sodium Tablets
Class IISubpotent Drug
Major Pharmaceuticals · Jul 13, 2026
Levothyroxine Sodium Tablets
Class IISubpotent Drug
Major Pharmaceuticals · Jul 13, 2026
Levothyroxine Sodium Tablets
Class IISubpotent Drug
Major Pharmaceuticals · Jul 13, 2026
BD ChloraPrep Clear
Class IILack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator
CareFusion 213, LLC · Jul 9, 2026
Amlodipine and Olmesartan Medoxomil Tablets
Class IIFailed Dissolution Specifications; Olmesartan Medoxomil content below specifications
Ascend Laboratories, LLC · Jul 8, 2026
Showing 40 of 1,769 recalls tracked.
Related: which FDA-approved drugs are no longer marketed — our discontinued-drugs report →
What the recall classes mean
- Class I
- Most serious — a reasonable probability that use will cause serious harm or death.
- Class II
- May cause temporary or medically reversible harm; low probability of serious harm.
- Class III
- Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Data source: U.S. FDA openFDA Drug Enforcement Reports. This page reproduces FDA recall data for reference and is not medical advice. Always follow the FDA's and your pharmacist's guidance.