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
Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Rx only…
Class IIIFailed dissolution specifications.
Supernus Pharmaceuticals, Inc. · Aug 31, 2026
Olanzapine Tablets
Class IIIFailed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
Macleods Pharmaceuticals Limited · Aug 27, 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
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
Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg
Class IIIPresence of Foreign Tablets/Capsules
Bionpharma Inc. · Aug 7, 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
Lidolog 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
Trokendi XR, topiramate extended-release capsules, 25mg, 30 Rx only…
Class IIIFailed Dissolution Specifications
Supernus Pharmaceuticals, Inc. · Jul 6, 2026
Dabigatran etexilate Capsules
Class IIIFailed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
Ascend Laboratories, LLC · Jun 30, 2026
Dabigatran etexilate Capsules
Class IIIFailed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
Ascend Laboratories, LLC · Jun 30, 2026
Primidone Tablets
Class IIICross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Amneal Pharmaceuticals, LLC · Jun 3, 2026
hydrOXYzine Hydrochloride Oral Solution
Class IIIPresence of foreign substance
ANI Pharmaceuticals, Inc. · Jun 2, 2026
Fexofenadine Hydrochloride Tablets
Class IIIFailed Impurities/Degradation Specifications
SUN PHARMACEUTICAL INDUSTRIES INC · Jun 1, 2026
Focalin XR (dexmethylphenidate HCl) 5 mg
Class IIILabeling: Incorrect or Missing Lot and/or Exp Date
Sandoz Inc · Jun 1, 2026
PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL…
Class IIIFailed Stability Specifications
AbbVie Inc. · May 18, 2026
Lidocaine HCl Injection
Class IIILabeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Eugia US LLC · May 18, 2026
Epinephrine Injection
Class IIIFailed Impurities/Degradations Specifications
Fresenius Kabi USA, LLC · May 14, 2026
Nicotine Transdermal System Patch
Class IIIFailed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
AVEVA Drug Delivery Systems, Inc. · May 14, 2026
Busulfan Injection
Class IIIFailed Impurities/Degradation Specifications
Sagent Pharmaceuticals · May 4, 2026
Primidone Tablets
Class IIICross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Amerisource Health Services LLC · May 1, 2026
Primidone Tablets
Class IIICross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Amerisource Health Services LLC · May 1, 2026
Primidone Tablets
Class IIICross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Golden State Medical Supply Inc. · Apr 27, 2026
Primidone Tablets
Class IIICross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Golden State Medical Supply Inc. · Apr 27, 2026
Primidone Tablets USP
Class IIICross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Lannett Company Inc. · Apr 24, 2026
Levocarnitine Injection
Class IIILabeling: Missing Label
American Regent, Inc. · Apr 16, 2026
Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only…
Class IIILabeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that this error is limited to the vial itself; the saleable unit of the box of 12 bottles has the correct expiration date printed.
Premier Dental Products Co · Apr 14, 2026
busPIRone Hydrochloride Tablets
Class IIISubpotent drug
Unichem Pharmaceuticals USA Inc. · Apr 13, 2026
Lidocaine Wound Gel (Benzalkonium Chloride
Class IIIFailed PH Specifications
Water-Jel Technologies, LLC · Apr 7, 2026
Magnesium Chloride
Class IIISubpotent drug
Avantor Performance Materials LLC · Mar 31, 2026
Skin Rehab, Calming Gel, Hydrocortisone Balm, 1%, .53oz net wt. (15.3g) per…
Class IIISubpotent Drug
Island Kinetics, Inc. d.b.a. CoValence Laboratories · Mar 18, 2026
Essential Calming Skin Gel
Class IIISubpotent Drug
Island Kinetics, Inc. d.b.a. CoValence Laboratories · Mar 18, 2026
Remedy Gel, hydrocortisone 1%, 30 mL/ 1 fl oz per bottle, Distributed By: glo…
Class IIISubpotent Drug
Island Kinetics, Inc. d.b.a. CoValence Laboratories · Mar 18, 2026
Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5…
Class IIIFailed Tablet/Capsule Specifications
Radnostix · Feb 19, 2026
Nilotinib Capsules
Class IIIFailed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Cipla USA, Inc. · Feb 18, 2026
Nilotinib Capsules
Class IIIFailed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Cipla USA, Inc. · Feb 18, 2026
Showing 40 of 176 Class III 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.