FDA-Drug2026-09-16Class IIICHEMICAL
Ajanta Pharma fluphenazine hydrochloride 1mg tablets recalled for failed impurity specifications
What this means
Ajanta Pharma USA Inc. is recalling fluphenazine hydrochloride 1mg tablets (NDC 27241-255-01) because stability testing at 18 months found organic impurity levels slightly above specification limits. The tablets contained 1.1% of Impurity-A, exceeding the 1.0% specification. No injuries have been reported.
- If you take fluphenazine tablets from lot DJ23254 (expires 11/30/2026) or lot DJ10205 (expires 04/30/2027), contact your pharmacy or doctor.
- Do not stop taking your medication without talking to your doctor first.
- Return unused tablets to your pharmacy for safe disposal.
The agency's original wording
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide within the U.S
Affected count
403,200 tablets
Manufactured in
400 Crossing Blvd Ste 102, Bridgewater, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0836-2026Want us to check the next one for you?
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