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.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: DJ23254, Exp. Date 11/30/2026; DJ10205, Exp. Date 04/30/2027.
Where it was sold
Nationwide within the U.S
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0836-2026
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Aug 25, 2026
- FDA report date
- Sep 16, 2026
- Quantity
- 403,200 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ajanta Pharma USA Inc
Original FDA data
Every field from FDA enforcement report D-0836-2026, exactly as published.
Show all FDA fields
- City
- Bridgewater
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 99733
- Address
- 400 Crossing Blvd Ste 102
- Code information
- Lot #: DJ23254, Exp. Date 11/30/2026; DJ10205, Exp. Date 04/30/2027.
- Postal code
- 08807-2863
- Report date
- Sep 16, 2026
- Product type
- Drugs
- Recall number
- D-0836-2026
- Classification
- Class III
- Recalling firm
- Ajanta Pharma USA Inc
- Product quantity
- 403,200 tablets
- Reason for recall
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide within the U.S
- Recall initiation date
- Aug 25, 2026
- Initial firm notification
- Letter
- Center classification date
- Sep 8, 2026