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Class III · Lower riskActive recall

Fluphenazine Hydrochloride

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot #: DJ23254, Exp. Date 11/30/2026; DJ10205, Exp. Date 04/30/2027.
Where it was soldNationwide within the U.S
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byMade in India foreign manufacturer
Brand nameFLUPHENAZINE HYDROCHLORIDE
Generic nameFLUPHENAZINE HYDROCHLORIDE
Active ingredient(s)FLUPHENAZINE HYDROCHLORIDE
Distributed by / forAjanta Pharma USA Inc
NDC27241-255-01
Show the full FDA record
Full product labelFluphenazine 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.
Recalling firmAjanta Pharma USA Inc
DistributionNationwide within the U.S
Quantity403,200 tablets
Recall initiated2026-08-25
Report date2026-09-16
Recall completed—
Recall numberD-0836-2026
ClassificationClass III
FDA statusOngoing
Origin on fileBridgewater NJ United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.