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
AcetaZOLAMIDE Tablets
Class IIIDiscoloration
Rubicon Research Private Limited · Aug 24, 2024
SEMAGLUTIDE 10mg/4mL (2.5mg/mL)
Class IILack of Assurance of Sterility
ProRx LLC · Aug 22, 2024
TIRZEPATIDE 20 mg/2mL (10/mg/mL)
Class IILack of Assurance of Sterility
ProRx LLC · Aug 22, 2024
TIRZEPATIDE 60 mg/3mL (20/mg/mL)
Class IILack of Assurance of Sterility
ProRx LLC · Aug 22, 2024
SEMAGLUTIDE 5mg/2mL (2.5mg/mL)
Class IILack of Assurance of Sterility
ProRx LLC · Aug 22, 2024
Semaglutide / Cyanocobalamin Injection: 2.5/0.5 mg/mL
Class IILack of Assurance of Sterility
ProRx LLC · Aug 22, 2024
Semaglutide, 2 mL (2.5mg/mL), Compounded RX Product, Multidose SC inj, glass…
Class IILack of Assurance of Sterility
ProRx LLC · Aug 22, 2024
Tirzepatide 2 mL (10 mg/mL) and 20
Class IILack of Assurance of Sterility
ProRx LLC · Aug 22, 2024
Cefixime for Oral Suspension USP
Class IISubpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
Lupin Pharmaceuticals Inc. · Aug 21, 2024
Just Right 5000
Class IIILABELING: LABEL MIX-UP.
Elevate Oral Care · Aug 20, 2024
Lidocaine HCl Injection
Class IILack of Assurance of Sterility
Fagron Compounding Services · Aug 15, 2024
Varithena (polidocanol injectable foam) Administration Pack
Class IIIDefective Delivery System: incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes packaged in the pack, instead of the required silicone oil-free NormJect 10 mL Luer Solo syringes (luer slip connection).
Biocompatibles UK, Ltd. · Aug 15, 2024
Timolol Maleate Ophthalmic Solution USP
Class IIDefective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
FDC Limited · Aug 12, 2024
Ibuprofen 800mg
Class IIFailed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
Direct Rx · Aug 9, 2024
Ibuprofen Tablets
Class IIFailed Impurities/Degradation Specifications - at 18-month Stability testing
Preferred Pharmaceuticals, Inc. · Aug 8, 2024
Testosterone Gel
Class IISuperpotent Drug
Teva Pharmaceuticals USA, Inc · Aug 8, 2024
Hydrocortisone 1% & Acetic Acid 2% Otic Solution
Class IIIFailed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
Taro Pharmaceuticals U.S.A., Inc. · Aug 7, 2024
IBU Ibuprofen Tablets
Class IIFailed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Dr. Reddy's Laboratories, Inc. · Aug 6, 2024
IBU Ibuprofen Tablets
Class IIFailed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Dr. Reddy's Laboratories, Inc. · Aug 6, 2024
IBU Ibuprofen Tablets
Class IIFailed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Dr. Reddy's Laboratories, Inc. · Aug 6, 2024
HAND-I-SAN, No-Rinse Hand Sanitizer (75% Isopropyl Alcohol), packaged in a)…
Class IICGMP Deviations: sterile water not used for production
Zeco LLC · Aug 5, 2024
Rubbing Alcohol (70% Isopropyl
Class IICGMP Deviations: sterile water not used for production
Zeco LLC · Aug 5, 2024
Empower Pharmacy
Class IILack of Assurance of Sterility
EMPOWER CLINIC SERVICES LLC · Aug 2, 2024
Methotrexate Tablets
Class IIIPresence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.
Amneal Pharmaceuticals, LLC · Aug 1, 2024
Heparin Sodium in 0.9% Chloride Injection)
Class IMicrobial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Baxter Healthcare Corporation · Aug 1, 2024
Gabapentin Tablets
Class IIPresence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets
Granules Pharmaceuticals Inc. · Jul 31, 2024
Indomethacin Extended-Release Capsules
Class IIFailed Dissolution Specifications: below specification results
Glenmark Pharmaceuticals Inc., USA · Jul 31, 2024
Progesterone Injection
Class IIPresence of Particulate Matter: Complaint received of a glass particle in the vial.
Eugia US LLC · Jul 26, 2024
0.9% Sodium Chloride Injection USP
Class IPresence of Particulate Matter
B. Braun Medical Inc · Jul 24, 2024
Ciprofloxacin ophthalmic solution USP
Class IIDefective container: unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
FDC Limited · Jul 23, 2024
Glenmark, Azelaic Acid Gel, 15 %, 50 grams, Rx only, Manufactured by…
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Jul 22, 2024
Umary Acido Hialuronico
Class IMarketed without Approved NDA/ANDA. FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
MAIN PRODUCTS INC · Jul 18, 2024
Timolol Maleate Ophthalmic Solution USP
Class IIDefective container; yellow colored spike from cap lodged in the nozzle
FDC Limited · Jul 18, 2024
Acetaminophen
Class IIILabel mix-up: Carton incorrectly labeled.
Granules Consumer Health Inc. · Jul 18, 2024
Hard Steel Capsules packaged in 1 count blister packs in boxes of 10
Class IMarketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Supercore Products Group Inc. · Jul 12, 2024
Umary Acido Hialuronico
Class IMarketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
SoloVital · Jul 12, 2024
Gold Hard Steel Plus Liquid
Class IMarketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Supercore Products Group Inc. · Jul 12, 2024
Healthy Living Acetaminophen
Class ILabeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
Aurobindo Pharma USA Inc · Jul 11, 2024
Clonazepam Orally Disintegrating Tablets
Class ILabeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside the product carton reflect the correct strength of 0.25 mg.
Endo Pharmaceuticals, Inc. · Jul 10, 2024
Nitrofurantoin Capsules
Class IIFailed Dissolution Specifications
SUN PHARMACEUTICAL INDUSTRIES INC · Jul 9, 2024
Showing 40 of 1,903 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.