Fluphenazine Hydrochloride Tablets recall
Ajanta Pharma USA Inc recalled Fluphenazine Hydrochloride Tablets on September 16, 2026 because of failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. It was sold nationwide.
Why it was recalled
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's 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.
Quantity: 403,200 tablets
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Ajanta Pharma USA Inc, Bridgewater, NJ
- Date
- Severity
- Class III
the product is unlikely to cause health problems but breaks a rule. - Where sold
- Nationwide
Nationwide within the U.S - Status
- Ongoing
- Recall number
- D-0836-2026
- Source
- U.S. Food and Drug Administration
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