Recall RadarFluphenazine 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.
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.
Read the official FDA notice →What to do
Stop using the product and check it against the description above. Follow the remedy on the official notice; most recalls are refunded or replaced without a receipt. If you or a family member has already been affected, keep the packaging and the lot code — they're what a claim rests on later.
Details
- Recalling company
- Ajanta Pharma USA Inc — Bridgewater, NJ
- Severity
- Class III — low
- Reported
- September 16, 2026
- Quantity
- 403,200 tablets
- Recall number
- D-0836-2026
- Status
- Ongoing
- Source
- FDA
Where it went
Nationwide within the U.S
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