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
Clear Eyes Redness Relief
Class IILack of Assurance of Sterility
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company · Sep 15, 2026
Clear Eyes Redness Relief
Class IILack of Assurance of Sterility
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company · Sep 15, 2026
Dopamine HCl Inj.
Class IILack of Assurance of Sterility
Pfizer · Sep 4, 2026
Chlorthalidone Tablets
Class IIFailed Dissolution Specifications
Inventia Healthcare Limited · Sep 3, 2026
fentaNYL Citrate
Class IILabeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product expiry (12/09/2026).
OurPharma LLC · Sep 3, 2026
Lidocaine Ointment USP
Class IIFailed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).
SUN PHARMA /TARO · Aug 31, 2026
Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Rx only…
Class IIIFailed dissolution specifications.
Supernus Pharmaceuticals, Inc. · Aug 31, 2026
Exenatide Injection
Class IIDefective Delivery System: Possibility of no medication in the prefilled pen.
Amneal Pharmaceuticals of New York, LLC · Aug 28, 2026
Olanzapine Tablets
Class IIIFailed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
Macleods Pharmaceuticals Limited · Aug 27, 2026
Carton label: Mycophenolate Mofetil for injection
Class IIFailed Dissolution Specifications
Mylan Pharmaceuticals Inc · Aug 26, 2026
Fluphenazine Hydrochloride Tablets
Class IIIFailed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0 percent.
Ajanta Pharma USA Inc · Aug 25, 2026
Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution
Class IIISubpotent Drug
ImprimisRx NJ LLC · Aug 24, 2026
traZODone Hydrochloride Tablets
Class IIPresence of Foreign Tablets/Capsules
Teva Pharmaceuticals USA, Inc · Aug 24, 2026
Ramipril Capsules USP
Class IIFailed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
Hikma Pharmaceuticals USA INC. · Aug 24, 2026
Thyroid Tablets
Class ISuperpotent Drug
VITRUVIAS THERAPEUTICS INC · Aug 21, 2026
Prasugrel HCI
Class IIFailed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution
Golden State Medical Supply Inc. · Aug 21, 2026
Broadway Joe's Pain Cream
Class IICGMP Deviations: Potential contamination of raw material
Lexia LLC · Aug 21, 2026
Broadway Joe's Pain Cream
Class IICGMP Deviations: Potential contamination of raw material
Lexia LLC · Aug 21, 2026
Reliable-1 Laboratories Lubricating Tears
Class IILack of Assurance of Sterility
Sterling Pharmaceutical Services LLC · Aug 20, 2026
Walgreens Lubricant Eye Drops
Class IILack of Assurance of Sterility
Sterling Pharmaceutical Services LLC · Aug 20, 2026
Major LubriFresh P.M. Nighttime Ointment
Class IILack of Assurance of Sterility
Sterling Pharmaceutical Services LLC · Aug 20, 2026
Walgreens Lubricant Eye Drops
Class IILack of Assurance of Sterility
Sterling Pharmaceutical Services LLC · Aug 20, 2026
Reliable -1 Laboratories
Class IILack of Assurance of Sterility
Sterling Pharmaceutical Services LLC · Aug 20, 2026
Lubricant Eye Drops-Cameron Pharmaceuticals
Class IILack of Assurance of Sterility
Sterling Pharmaceutical Services LLC · Aug 20, 2026
AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%
Class IILack of Assurance of Sterility
Sterling Pharmaceutical Services LLC · Aug 20, 2026
AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%
Class IILack of Assurance of Sterility
Sterling Pharmaceutical Services LLC · Aug 20, 2026
TRP The Relief Products* Gentle Eyes Lubricant Eye Drops
Class IILack of Assurance of Sterility
Sterling Pharmaceutical Services LLC · Aug 20, 2026
0.9% Sodium Chloride Injection
Class IPresence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene
B BRAUN MEDICAL INC · Aug 19, 2026
Revcovi (elapegademase-lvlr) Injection
Class IIIFailed Stability Specifications: Out of specification stability result for the protein concentration profile.
Chiesi USA, Inc. · Aug 19, 2026
Buprenorphine Sublingual Tablets (C-III)
Class IIILabeling: Label Mix-up
American Health Packaging · Aug 19, 2026
2% Chlorhexidine Gluconate* Cloth
Class IICross Contamination with Other Products
Sage Products, LLC · Aug 18, 2026
Prasugrel Tablets
Class IIFailed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
Mylan Pharmaceuticals Inc · Aug 17, 2026
Dextrose Injection
Class IPresence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
Baxter Healthcare Corporation · Aug 17, 2026
0.9% Sodium Chloride Injection USP 500 mL
Class IPresence of particulate matter: Particulates identified as fiberglass
Baxter Healthcare Corporation · Aug 17, 2026
THE ONE SPF 50 INVISIBLE SUNSCREEN GEL
Class IISubpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
Allies Group Inc. · Aug 14, 2026
THE ONE SPF 50 INVISIBLE SUNSCREEN GEL
Class IISubpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
Allies Group Inc. · Aug 14, 2026
THE ONE SPF 50 INVISIBLE SUNSCREEN GEL
Class IISubpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
Allies Group Inc. · Aug 14, 2026
THE ONE SPF 50 INVISIBLE SUNSCREEN GEL
Class IISubpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
Allies Group Inc. · Aug 14, 2026
Fluphenazine HCl Elixir
Class IIFailed Stability Specifications
Safecor Health, LLC · Aug 13, 2026
Fluphenazine HCl Elixir
Class IIFailed Stability Specifications
Safecor Health, LLC · Aug 13, 2026
Showing 40 of 1,895 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.