Drug recall D-0836-2026
Product
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.
Lots and codes
Lot #: DJ23254, Exp. Date 11/30/2026; DJ10205, Exp. Date 04/30/2027.
Recall details
- Recalling firm
- Ajanta Pharma USA Inc, Bridgewater, NJ
- Quantity
- 403,200 tablets
- Distribution
- Nationwide within the U.S
- Type
- Voluntary: Firm initiated
- Recall initiated
- August 25, 2026
Related products
- Fluphenazine Hydrochloride – drug information
- NDC 27241-253 Fluphenazine hydrochloride · Fluphenazine Hydrochloride 5 mg/1 · Ajanta Pharma USA Inc.
- NDC 27241-254 Fluphenazine hydrochloride · Fluphenazine Hydrochloride 2.5 mg/1 · Ajanta Pharma USA Inc.
- NDC 27241-252 Fluphenazine hydrochloride · Fluphenazine Hydrochloride 10 mg/1 · Ajanta Pharma USA Inc.
- NDC 27241-255 Fluphenazine hydrochloride · Fluphenazine Hydrochloride 1 mg/1 · Ajanta Pharma USA Inc.