D-0836-2026 Class III Ongoing
FDA drug recall D-0836-2026 was initiated by Ajanta Pharma USA Inc on August 25, 2026 and is designated Class III. 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. The recall status is ongoing. Affected quantity: 403,200 tablets.
Recall Details
- Product Type
- Drugs
- Report Date
- September 16, 2026
- Initiation Date
- August 25, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 403,200 tablets
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.
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.
Distribution Pattern
Nationwide within the U.S
Code Information
Lot #: DJ23254, Exp. Date 11/30/2026; DJ10205, Exp. Date 04/30/2027.