FDAFDA · Food and drugs·Recall number D-0836-2026
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.
Published September 16, 2026 · Recall initiated: August 25, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Brand
- FLUPHENAZINE HYDROCHLORIDE
- Manufacturer
- Ajanta Pharma USA Inc
- Distributor
- Nationwide within the U.S
- UPC
- 0327241255014
- Lot
- Lot #: DJ23254, Exp. Date 11/30/2026; DJ10205, Exp. Date 04/30/2027.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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