← Every firm

Ajanta Pharma USA Inc FDA Recalls

3 recalls on file across drugs, 0 of them Class I and 3 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product
Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Marketed by: Ajanta Pharma USA Inc., BridgewaClass IIIAug 25, 2026Failed impurities/degradation specifications: (OOS) for Orga
Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma Limited, India, Marketed by: AjaClass IIMay 28, 2026CGMP Deviations
Aripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made iClass IIMay 27, 2026Product Mix-Up: A bottle containing Voriconazole Tablets 50

Related datasets