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
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
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
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
Potassium Chloride Extended-Release Capsules
Class IFailed Dissolution Specifications
Amerisource Health Services LLC · Jun 25, 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
STELLALIFE VEGA Oral Care
Class IMicrobial Contamination of Non-Sterile Products: multiple Bacillus species organisms
Homeocare Laboratories, Inc. · Jun 5, 2024
Potassium Chloride Extended-Release Capsules
Class IFailed Dissolution Specifications
Glenmark Pharmaceuticals Inc., USA · May 30, 2024
Potassium Chloride Extended-Release Capsules
Class IFailed Dissolution Specifications
Glenmark Pharmaceuticals Inc., USA · May 30, 2024
Docetaxel Injection
Class IPresence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Sagent Pharmaceuticals · May 28, 2024
Docetaxel Injection
Class IPresence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Sagent Pharmaceuticals · May 28, 2024
suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broad S…
Class IMicrobial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
SYNCHRONICITY SPA INC, DBA SUNTE · May 24, 2024
Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free
Class ILabeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.
Hikma Injectables USA Inc · Apr 29, 2024
Schwinnng Herbal Dietary Supplement Capsules
Class IMarketed Without An Approved NDA/ANDA
Stop Clopez Corp · Apr 22, 2024
Tirzepatide 10 mg/0.5 mL Sterile Solution
Class ILabeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate
Revive Rx LLC dba Revive Rx Pharmacy · Apr 20, 2024
Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg
Class ISub-potent Drug; powder discoloration associated with decreased potency
Dr. Reddy's Laboratories, Inc. · Apr 8, 2024
Sapropterin Dihydrochloride Powder for Oral Solution 100mg
Class ISub-potent Drug; powder discoloration associated with decreased potency
Dr. Reddy's Laboratories, Inc. · Apr 8, 2024
Atovaquone Oral Suspension USP
Class IMicrobial contamination of a non-sterile product: potential Bacillus cereus contamination.
AvKARE · Mar 28, 2024
Aruba Aloe Hand Sanitizer Gel
Class IChemical Contamination: Product manufactured with ethanol API that contains methanol
Aruba Aloe Balm N.V. · Mar 23, 2024
Alcoholada Gel
Class IChemical Contamination: Product manufactured with ethanol API that contains methanol
Aruba Aloe Balm N.V. · Mar 23, 2024
Vancomycin Hydrochloride for Oral Solution
Class ISuperpotent Drug: Due to overfilling of drug powder
Amneal Pharmaceuticals of New York, LLC · Mar 21, 2024
GoHARD 25000
Class IMarketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Pyramids Wholesale Inc. · Mar 19, 2024
libigrow RED DRAGON+
Class IMarketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Pyramids Wholesale Inc. · Mar 19, 2024
The GOAT SUBLINGUAL STRIP
Class IMarketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Pyramids Wholesale Inc. · Mar 19, 2024
SILVERBACK XXX POWER MALE ENHANCEMENT
Class IMarketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Pyramids Wholesale Inc. · Mar 19, 2024
HONEY MANUKA BUNNY LOVE
Class IMarketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Pyramids Wholesale Inc. · Mar 19, 2024
ALPHASTRIP MALE PERFORMANCE ENHANCER
Class IMarketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Pyramids Wholesale Inc. · Mar 19, 2024
Samurai-X Honey 6800
Class IMarketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Pyramids Wholesale Inc. · Mar 19, 2024
Spanish Fly 22K capsules
Class IMarketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Pyramids Wholesale Inc. · Mar 19, 2024
Pink Pussycat Honey
Class IMarketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Pyramids Wholesale Inc. · Mar 19, 2024
Flower Power
Class IMarketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Pyramids Wholesale Inc. · Mar 19, 2024
Weiner Boner Honey
Class IMarketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Pyramids Wholesale Inc. · Mar 19, 2024
Treprostinil Injection
Class IPresence of Particulate Matter.
Par Sterile Products LLC · Mar 4, 2024
Methocarbamol Injection
Class IPresence of Particulate Matter
Eugia US LLC · Feb 15, 2024
ForeverMen Natural Energy Boost Capsules
Class IMarketed Without an Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this unapproved drug.
FA Online Inc · Feb 12, 2024
Sustain Herbal Dietary Supplement
Class IMarketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this drug an unapproved drug.
Today The World · Feb 6, 2024
SCHWINNNG Herbal Dietary Supplement
Class IMarketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.
Today The World · Feb 6, 2024
Showing 40 of 129 Class I 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.