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.

FDA recall notice · announced September 16, 2026 · Ajanta Pharma

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Notes

Distribution: Nationwide within the U.S
Lot/code information: Lot #: DJ23254, Exp. Date 11/30/2026; DJ10205, Exp. Date 04/30/2027.
Quantity: 403,200 tablets
Status: Ongoing
Products in this recall event:
- 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. (D-0836-2026)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.