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
Fosaprepitant for Injection 150 mg per vial
Class IILack of Sterility Assurance: Aseptic process simulation failure.
BE PHARMACEUTICALS AG · Jan 10, 2024
Medline Remedy Clinical TREAT Antifungal Cream
Class IILabeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while the product does in fact contain parabens as part of the formulation/ ingredient list.
MEDLINE INDUSTRIES, LP - Northfield · Jan 10, 2024
Budesonide Extended-Release Tablets 9mg
Class IIFailed Dissolution Specifications
Teva Pharmaceuticals USA, Inc · Jan 8, 2024
Rifampin Capsules USP 300mg
Class IISubpotent Drug and Failed Impurities/Degradation Specifications
Lupin Pharmaceuticals Inc. · Jan 5, 2024
Rifampin Capsules USP 150mg
Class IISubpotent Drug and Failed Impurities/Degradation Specifications
Lupin Pharmaceuticals Inc. · Jan 5, 2024
Fluocinolone Acetonide Oil
Class IIFailed Excipient Specifications: OOS for assay of Isopropyl Alcohol
Glenmark Pharmaceuticals Inc., USA · Jan 4, 2024
Zenzedi (Dextroamphetamine Sulfate) CII Tablets
Class ILabeling: Label Mix-up
Azurity Pharmaceuticals, Inc. · Jan 4, 2024
Cefixime for Oral Suspension 100mg/5mL
Class IIFailed Impurities/Degradation Specifications
Lupin Pharmaceuticals Inc. · Jan 3, 2024
Tizanidine Tablets
Class IIPresence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.
Dr. Reddy's Laboratories, Inc. · Jan 2, 2024
Showing 9 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.