Ajanta Pharma USA Inc recalls Fluphenazine Hydrochloride Tablets
- Recalling company
- Ajanta Pharma USA Inc
- 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
- 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.
- Classification
- Class III – not likely to cause adverse health consequences
- Recall date
- Aug 25, 2026
- Reported
- Sep 16, 2026
- Distribution
- Nationwide within the U.S
- Status
- Ongoing
- Quantity
- 403,200 tablets
- Lot / codes
- Lot #: DJ23254, Exp. Date 11/30/2026; DJ10205, Exp. Date 04/30/2027.
- Company location
- Bridgewater, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0836-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0836-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.