Class IIIDrugOngoing

Ajanta Pharma USA Inc

Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-255-01.

Reason for recall

Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0 percent.

Details

Recall number: D-0836-2026
Event ID: 99733
Recall initiated: Aug 25, 2026
Classified: Sep 8, 2026
Reported: Sep 16, 2026
Quantity: 403,200 tablets
Distribution: Nationwide within the U.S
Initiated by: Voluntary: Firm initiated
Firm notification: Letter
Firm location: Bridgewater, NJ, United States
Lot / code info: Lot #: DJ23254, Exp. Date 11/30/2026; DJ10205, Exp. Date 04/30/2027.