United StatesFluphenazine Hydrochloride Tablets, USP, 1 mg, 100‑count bottles (NDC 27241‑255‑01) marketed by Ajanta Pharma USA Inc., lots DJ23254 (exp. 11/30/2026) and DJ10205 (exp. 04/30/2027), made in India and sold nationwide in the U.S., are affected. The lots are being recalled because they failed impurities/degradation specifications—Impurity‑A measured 1.1% versus the 1.0% specification during 18‑month stability testing.
What's being recalled
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.
Recalling firm: Ajanta Pharma USA Inc, Bridgewater, NJ, United States.
How to identify it
Lot #: DJ23254, Exp. Date 11/30/2026; DJ10205, Exp. Date 04/30/2027.
The hazard
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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide within the U.S
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)