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.
Class III · Ongoing
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.
Advertisement
Advertisement
Affected lots / codes — check yours against thisLot #: DJ23254, Exp. Date 11/30/2026; DJ10205, Exp. Date 04/30/2027.
- Recalling firm
- Ajanta Pharma USA Inc, Bridgewater, NJ
- Classification
- Class III (unlikely to cause harm)
- Status
- Ongoing
- Quantity
- 403,200 tablets
- Distribution
- Nationwide within the U.S
- Recall initiated
- August 25, 2026
- Classified
- September 8, 2026
- Initiation
- Voluntary: Firm initiated
Advertisement
Official source. This record is published by the U.S. FDA through the openFDA
enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0836-2026%22
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0836-2026%22
Advertisement
Important. Recalls target specific lots and codes — compare the affected lots
above against your own product. This page reproduces public FDA data for readability;
EveryRecall is independent and not affiliated with the FDA.
Check this brand across all 8 databases →