220 recalls · Class I, newest first
Reason Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone and chlorpheniramine.
Reason Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Reason Presence of Particulate Matter
Reason Marketed without Approved NDA/ANDA. FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
Reason Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
Reason Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Reason Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Reason Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
Reason Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection…
Reason Failed Dissolution Specifications
Reason Failed Dissolution Specifications
Reason Failed Dissolution Specifications
Reason Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Reason Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Reason Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
Reason Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate
Reason Sub-potent Drug; powder discoloration associated with decreased potency
Reason Sub-potent Drug; powder discoloration associated with decreased potency
Reason Chemical Contamination: Product manufactured with ethanol API that contains methanol
Reason Chemical Contamination: Product manufactured with ethanol API that contains methanol
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.