Class I · High risk Ongoing
Vail-Bon Jie Yang Wan capsules
Reason Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone and chlorpheniramine.
FDA Drug Recalls
220 recalls · Class I, newest first
Class I · High risk Ongoing
Heparin
Reason Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Class I · High risk Ongoing
0.9% Sodium Chloride Injection USP
Reason Presence of Particulate Matter
Class I · High risk Ongoing
Umary Acido Hialuronico
Reason Marketed without Approved NDA/ANDA. FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
Class I · High risk Ongoing
Umary Acido Hialuronico
Reason Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
Class I · High risk Ongoing
Gold Hard Steel Plus Liquid
Reason Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Class I · High risk Ongoing
Hard Steel Capsules packaged in 1 count blister packs in boxes of 10
Reason Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Class I · High risk Ongoing
Healthy Living Acetaminophen
Reason Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
Class I · High risk Ongoing
Acetaminophen Injection
Reason Labeling: 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)
Class I · High risk Ongoing
Potassium Chloride Extended-Release Capsules
Reason Failed Dissolution Specifications
Class I · High risk Ongoing
Potassium Chloride Extended-Release Capsules
Reason Failed Dissolution Specifications
Class I · High risk Ongoing
Potassium Chloride Extended-Release Capsules
Reason Failed Dissolution Specifications
Class I · High risk Ongoing
Docetaxel Injection
Reason Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Class I · High risk Ongoing
Docetaxel Injection
Reason Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Class I · High risk Ongoing
suntegrity
Reason Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
Class I · High risk Ongoing
Tirzepatide 10 mg/0.5 mL Sterile Solution
Reason Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate
Class I · High risk Ongoing
Sapropterin Dihydrochloride Powder for Oral Solution 100mg
Reason Sub-potent Drug; powder discoloration associated with decreased potency
Class I · High risk Ongoing
Javygtor
Reason Sub-potent Drug; powder discoloration associated with decreased potency
Class I · High risk Ongoing
Aruba Aloe Hand Sanitizer Gel
Reason Chemical Contamination: Product manufactured with ethanol API that contains methanol
Class I · High risk Ongoing
Alcoholada Gel
Reason Chemical Contamination: Product manufactured with ethanol API that contains methanol
Class I · High risk Ongoing
Honey Manuka Bunny Love
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk Ongoing
Alphastrip Male Performance Enhancer
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk Ongoing
The GOAT SUBLINGUAL STRIP
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk Ongoing
Silverback Xxx Power Male Enhancement
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk Ongoing
libigrow RED DRAGON+
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.