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
SEMAGLUTIDE 5mg (1mg/mL)
Class IIPresence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Apollo Care, LLC · Jul 29, 2026
SEMAGLUTIDE 4.5mg (0.9 mg/mL)
Class IIPresence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Apollo Care, LLC · Jul 29, 2026
SEMAGLUTIDE 9mg (4.5 mg/mL)
Class IIPresence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Apollo Care, LLC · Jul 29, 2026
SEMAGLUTIDE 10mg (5mg/mL)
Class IIPresence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Apollo Care, LLC · Jul 29, 2026
SEMAGLUTIDE 20mg (5mg/mL)
Class IIPresence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Apollo Care, LLC · Jul 29, 2026
CLEAR EYES Maximum Itchy Eye Relief
Class IILack of assurance of sterility. The recall is due to potential contamination
Prestige Brands Holdings · Jul 29, 2026
SEMAGLUTIDE 0.9mg (0.9 mg/mL)
Class IIPresence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Apollo Care, LLC · Jul 29, 2026
SEMAGLUTIDE 6.75mg (4.5 mg/mL)
Class IIPresence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Apollo Care, LLC · Jul 29, 2026
SEMAGLUTIDE 2.5mg (1mg/mL)
Class IIPresence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Apollo Care, LLC · Jul 29, 2026
SEMAGLUTIDE 2.25MG (0.9 mg/mL)
Class IIPresence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Apollo Care, LLC · Jul 29, 2026
SEMAGLUTIDE 12.5MG (2.5MG/mL)
Class IIPresence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Apollo Care, LLC · Jul 29, 2026
SEMAGLUTIDE 7.5mg (5mg/mL)
Class IIPresence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Apollo Care, LLC · Jul 29, 2026
Libtayo (cemiplimab-rwlc) Injection
Class IILack of Assurance of Sterility
Regeneron Pharmaceuticals Inc · Jul 28, 2026
Tralement (trace elements injection 4*
Class IIPresence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
American Regent, Inc. · Jul 24, 2026
Cyanocobalamin injection USP
Class IIPresence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
American Regent, Inc. · Jul 24, 2026
Selenious Acid Injection
Class IIPresence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
American Regent, Inc. · Jul 24, 2026
AMINAOCAPROIC ACID INJECTION
Class IIPresence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
American Regent, Inc. · Jul 24, 2026
niCARdipine Hydrochloride Injection
Class IIPresence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
American Regent, Inc. · Jul 24, 2026
Acamprosate Calcium
Class IIFailed Dissolution Specifications
Mylan Pharmaceuticals Inc · Jul 24, 2026
Nitroglycerin injection
Class IIPresence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
American Regent, Inc. · Jul 24, 2026
Atropine Sulfate injection
Class IIPresence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
American Regent, Inc. · Jul 24, 2026
ACETYLCYSTEINE SOLUTION
Class IIPresence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
American Regent, Inc. · Jul 24, 2026
ACETYLCYSTEINE SOLUTION
Class IIPresence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
American Regent, Inc. · Jul 24, 2026
Multrys (Trace Elements Injection 4
Class IIPresence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
American Regent, Inc. · Jul 24, 2026
Cyanocobalamin injection USP
Class IIPresence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
American Regent, Inc. · Jul 24, 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
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
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 (hypromellose 0.35%
Class IILack of Assurance of Sterility
Rohto-Mentholatum (Vietnam) Co., Ltd. · Jul 14, 2026
Showing 40 of 1,576 Class II recalls (1,895 tracked in total).
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.