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
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, 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
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, Steril…
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, Manufactur…
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 Skin Gel, Hydrocortisone Balm, hydrocortisone 1%, .53oz net…
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 Sk…
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 empt…
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
Eptifibatide Injection
Class IIILabeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/100 mL vial for weight-adjusted infusion.
Slate Run Pharmaceuticals · Feb 12, 2026
Pitavastatin Tablets
Class IIIPresence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
Annora Pharma Private Limited · Feb 3, 2026
Doxazosin Tablets
Class IIITablets/Capsules Imprinted with Wrong ID
Unichem Pharmaceuticals USA Inc. · Jan 21, 2026
Fluocinolone Acetonide Solution Topical Solution USP
Class IIIFailed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
SUN PHARMACEUTICAL INDUSTRIES INC · Dec 30, 2025
parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH
Class IIILabeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles.
Haleon US Holdings LLC · Dec 26, 2025
Diclofenac Sodium Topical Gel
Class IIIFailed PH Specifications
Cipla USA, Inc. · Dec 22, 2025
traZODONE Hydrochloride Tablets
Class IIIFailed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Zydus Pharmaceuticals (USA) Inc · Dec 19, 2025
Fesoterodine Fumarate
Class IIIFailed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Alembic Pharmaceuticals Limited · Dec 16, 2025
Showing 40 of 168 Class III recalls (1,769 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.