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
Equate Cherry Cough Drops
Class IICGMP Deviations: Potential Glass and Silicone particulates in product
Bestco LLC · Jan 19, 2024
Kroger Cherry Cough Drops
Class IICGMP Deviations: Potential Glass and Silicone particulates in product
Bestco LLC · Jan 19, 2024
Meijer Cherry Cough Drops
Class IICGMP Deviations: Potential Glass and Silicone particulates in product
Bestco LLC · Jan 19, 2024
CVS Health Cherry Cough Drops
Class IICGMP Deviations: Potential Glass and Silicone particulates in product
Bestco LLC · Jan 19, 2024
Fexofenadine Hydrochloride Tablets
Class IICGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
SUN PHARMACEUTICAL INDUSTRIES INC · Jan 18, 2024
Zolpidem Tartrate Extended-Release Tablets
Class IICGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
SUN PHARMACEUTICAL INDUSTRIES INC · Jan 18, 2024
Febuxostat Tablets 40mg
Class IICGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
SUN PHARMACEUTICAL INDUSTRIES INC · Jan 18, 2024
Febuxostat Tablets 80 mg
Class IICGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
SUN PHARMACEUTICAL INDUSTRIES INC · Jan 18, 2024
Niacin Extended-Release Tablets
Class IICGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
SUN PHARMACEUTICAL INDUSTRIES INC · Jan 18, 2024
Niacin Extended-Release Tablets
Class IICGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
SUN PHARMACEUTICAL INDUSTRIES INC · Jan 18, 2024
Lurasidone Hydrochloride Tablets 120mg
Class IICGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
SUN PHARMACEUTICAL INDUSTRIES INC · Jan 18, 2024
Cinacalcet Tablets 60mg
Class IICGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
SUN PHARMACEUTICAL INDUSTRIES INC · Jan 18, 2024
Mesalamine Delayed-Release Tablets
Class IICGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
SUN PHARMACEUTICAL INDUSTRIES INC · Jan 18, 2024
Zolpidem Tartrate Extended-Release Tablets
Class IICGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
SUN PHARMACEUTICAL INDUSTRIES INC · Jan 18, 2024
Lurasidone Hydrochloride Tablets 60mg
Class IICGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
SUN PHARMACEUTICAL INDUSTRIES INC · Jan 18, 2024
Adrenalin (epinephrine) Injection 1mg/mL
Class IILabeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.
Henry Schein Inc. and Glove Club HSI Gloves Inc. · Jan 17, 2024
Fosfomycin Tromethamine Granules for Oral Solution
Class IIFailed Impurities/Degradation Specification: Out of specification for organic impurities
Ascend Laboratories, LLC · Jan 16, 2024
OralProCare medicated lip treatment
Class IICGMP Deviations: products may not conform to the labeled specifications.
Den-Mat Holdings, LLC · Jan 16, 2024
Hydrogen Peroxide Oral Rinse
Class IICGMP Deviations: products may not conform to the labeled specifications.
Den-Mat Holdings, LLC · Jan 16, 2024
Phenoxybenzamine Hydrochloride Capsules
Class IIFailed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Amneal Pharmaceuticals of New York, LLC · Jan 15, 2024
Vasopressin 2 Unit/2 mL in 0.9% Sodium Chloride
Class IISubpotent Drug
IntegraDose Compounding Services LLC · Jan 12, 2024
Budesonide Extended-Release Tablets
Class IIFailed Dissolution Specifications
Golden State Medical Supply Inc. · Jan 12, 2024
Rifampin Capsules USP
Class IIFailed Impurities/Degradation Specification.
Amerisource Health Services LLC · Jan 11, 2024
Vasostrict (vasopressin in 5% Dextrose) Injection
Class IISuperpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.
Par Sterile Products LLC · Jan 11, 2024
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
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 32 of 1,472 Class II 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.