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
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…
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…
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
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
DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / CALCIUM 4.25%…
Class IIThis product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
Fresenius Medical Care Holdings, Inc. · Jun 18, 2024
Venlafaxine Hydrochloride
Class IIFailed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Jun 18, 2024
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose
Class IILack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.
Baxter Healthcare Corporation · Jun 17, 2024
Methylphenidate Hydrochloride
Class IIFailed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
Trigen Laboratories · Jun 17, 2024
Zilretta (triamcinolone acetonide extended-release injectable suspension)
Class IIFailed Dissolution Specifications - did not meet the acceptance criteria for IVR Level 3 testing at 9 months 2-8¿C followed by 6 weeks at 25¿C
PACIRA PHARMACEUTICALS INC · Jun 12, 2024
Oatmeal Daily Moisturizing Body Lotion (1.3% Dimethicone)
Class IIMicrobial Contamination of Non-Sterile Products: confirmed presence of mold contamination
Brands International Corporation · Jun 10, 2024
Allopurinol Tablets
Class IIPresence of foreign substance.
Dr. Reddy's Laboratories, Inc. · Jun 7, 2024
STELLALIFE ADVANCED FORMULA Peppermint
Class IIMicrobial Contamination of Non-Sterile Products: presence of Terribacillus species organism
Homeocare Laboratories, Inc. · Jun 5, 2024
Amoxicillin and Clavulanate Potassium Tablets USP
Class IISubpotent Drug
Teva Pharmaceuticals USA, Inc · Jun 4, 2024
Phenazopyridine HCl
Class IIProduct Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
RemedyRepack Inc. · May 31, 2024
Potassium Chloride Extended-Release Capsules
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · May 30, 2024
Potassium Chloride Extended-Release Capsules
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · May 30, 2024
Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size)
Class IIFailed Content Uniformity Specifications
Lupin Pharmaceuticals Inc. · May 30, 2024
Little Remedies Gas Relief Drops (Simethicone/Antigas)
Class IIcGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
Denison Pharmaceuticals, LLC · May 28, 2024
Showing 40 of 1,576 Class II recalls (1,895 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.