Class I · High risk
Ascorbic Acid Inj. Solution
Presence of Particulate Matter: Presence of glass particulates.
FDA Drug Recalls
12 recalls · Class I, newest first
Class I · High risk
Veklury (remdesivir)
Presence of Particulate Matter: Presence of glass particle.
Class I · High risk
Atovaquone Oral Suspension
Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
Class I · High risk
Clonazepam Orally Disintegrating Tablets
Labeling: 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.
Class I · High risk
Acetaminophen Extra Strength Tablets
Labeling: 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.
Class I · High risk
STELLALIFE VEGA Oral Care
Microbial Contamination of Non-Sterile Products: multiple Bacillus species organisms
Class I · High risk
Schwinnng Herbal Dietary Supplement Capsules
Marketed Without An Approved NDA/ANDA
Class I · High risk
Atovaquone Oral Suspension USP
Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
Class I · High risk
Vancomycin Hydrochloride for Oral Solution
Superpotent Drug: Due to overfilling of drug powder
Class I · High risk
ForeverMen Natural Energy Boost Capsules
Marketed 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.
Class I · High risk
Neptune's Fix
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Class I · High risk
Zenzedi (Dextroamphetamine Sulfate)
Labeling: Label Mix-up