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
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 via…
Class IILack of Assurance of Sterility
ProRx LLC · Aug 22, 2024
Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL
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
Lidocaine HCl Injection
Class IILack of Assurance of Sterility
Fagron Compounding Services · 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
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) 3.7…
Class IICGMP Deviations: sterile water not used for production
Zeco LLC · Aug 5, 2024
Rubbing Alcohol (70% Isopropyl Alcohol)
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
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
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: Glenmark P…
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Jul 22, 2024
Timolol Maleate Ophthalmic Solution USP
Class IIDefective container; yellow colored spike from cap lodged in the nozzle
FDC Limited · Jul 18, 2024
Nitrofurantoin Capsules
Class IIFailed Dissolution Specifications
SUN PHARMACEUTICAL INDUSTRIES INC · Jul 9, 2024
Lidocaine HCL Injection
Class IISubpotent Drug: reduced efficacy for epinephrine
TAILSTORM HEALTH INC · Jul 3, 2024
Decitabine for Injection 50mg per vial
Class IICGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.
SUN PHARMACEUTICAL INDUSTRIES INC · Jul 2, 2024
Pravastatin Sodium Tablets
Class IIFailed Dissolution Specifications: results below specifications
Glenmark Pharmaceuticals Inc., USA · Jun 28, 2024
Fludrocortisone Acetate Tablets
Class IIFailed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits.
Teva Pharmaceuticals USA, Inc · Jun 28, 2024
Cyanocobalamin Injection
Class IIPresence of particulate matter: glass
Zydus Pharmaceuticals (USA) Inc · Jun 27, 2024
Infla-650 Herbal Dietary Supplement
Class IIMarketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone.
Guru Inc. · Jun 26, 2024
Blemfree All Day Lotion (salicylic acid 0.5% w/w)
Class IICGMP Deviations: Manufactured without following Current Good Manufacturing Practises.
Equibal Inc · Jun 26, 2024
Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline p…
Class IICGMP Deviations and Presence of Particulate Matter: Glass
Medisca Inc. · Jun 26, 2024
Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules
Class IICGMP Deviations: Out of specification for dissolution
RemedyRepack Inc. · Jun 26, 2024
buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily
Class IIFailed Dissolution Specifications; the product is dissolving faster than the specified limits.
Amerisource Health Services LLC · Jun 24, 2024
Venlafaxine Hydrochloride Extended-Release Capsules
Class IIFailed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
Zydus Pharmaceuticals (USA) Inc · Jun 21, 2024
Little Moon Essentials
Class IICGMP deviations
Little Moon Essentials LLC · Jun 20, 2024
Little Moon Essentials
Class IICGMP deviations
Little Moon Essentials LLC · Jun 20, 2024
Little Moon Essentials
Class IICGMP deviations
Little Moon Essentials LLC · Jun 20, 2024
Little Moon Essentials
Class IICGMP deviations
Little Moon Essentials LLC · Jun 20, 2024
Little Moon Essentials
Class IICGMP deviations
Little Moon Essentials LLC · Jun 20, 2024
Little Moon Essentials
Class IICGMP deviations
Little Moon Essentials LLC · Jun 20, 2024
Showing 40 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.