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
Acetaminophen Injection
Class ILabeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL)
Hikma Pharmaceuticals USA Inc. · Jul 8, 2024
Lidocaine HCL Injection
Class IISubpotent Drug: reduced efficacy for epinephrine
TAILSTORM HEALTH INC · Jul 3, 2024
Micafungin for injection
Class IIICross contamination with other products
Zydus Pharmaceuticals (USA) Inc · Jul 2, 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
PEG-3350, Sodium Sulfate, Chloride, Potassium Ascorbate, and Ascorbic Acid for…
Class IIIDefective container: potential for non-sealed pouches which can lead to product leakage.
Novel Laboratories, Inc. d.b.a Lupin Somerset · Jul 2, 2024
Micafungin for injection
Class IIICross contamination with other products
Zydus Pharmaceuticals (USA) Inc · Jul 2, 2024
Verapamil Hydrochloride Injection
Class IIICross contamination with other products.
Zydus Pharmaceuticals (USA) Inc · Jul 2, 2024
Verapamil Hydrochloride Injection
Class IIICross contamination with other products.
Zydus Pharmaceuticals (USA) 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
Sevelamer Carbonate for Oral Suspension 0.8g packets
Class IIILabeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets
Dr. Reddy's Laboratories, Inc. · Jun 26, 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
Hemp Bombs CBD Pain Freeze (menthol 4%)
Class IIISubpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
GLOBAL WIDGET LLC · Jun 25, 2024
Hemp Bombs CBD Pain Freeze (menthol 4%)
Class IIISubpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
GLOBAL WIDGET LLC · Jun 25, 2024
Nature's Script CBD Cryotherapy Pain Relief Roll on (menthol 4%) 200mg
Class IIISubpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
GLOBAL WIDGET LLC · Jun 25, 2024
Hemp Bombs CBD Pain Freeze (menthol 4%)
Class IIISubpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
GLOBAL WIDGET LLC · Jun 25, 2024
Potassium Chloride Extended-Release Capsules
Class IFailed Dissolution Specifications
Amerisource Health Services LLC · Jun 25, 2024
SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution
Class IIISub-potent Drug
Neilmed Pharmaceuticals Inc · Jun 24, 2024
Diflorasone Diacetate Ointment
Class IIIFailed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
Rising Pharma Holding, Inc. · Jun 24, 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
Acetaminophen Extra Strength Tablets
Class ILabeling: Label Mix-Up: Some bottles of Acetaminophen Extra Strength 500 mg tablets were incorrectly labeled with the drug facts label for Aspirin 81 mg tablets.
A-S Medication Solutions LLC · Jun 21, 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
Dodex Injectable (Cyanocobalamin Injection) USP
Class IIISubpotent drug: out of specification results
Accord Healthcare, Inc. · 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
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.