Fluphenazine Hydrochloride Tablets — Class III drug recall D-0836-2026
Ongoing recall by Ajanta Pharma USA Inc, reported 2026-09-16, distributed nationwide. Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing
| Recall number | D-0836-2026 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ajanta Pharma USA Inc, Bridgewater, NJ, United States |
| Recall initiated | 2026-08-25 |
| Classified | 2026-09-08 |
| Reported by FDA | 2026-09-16 |
| Distributed | Nationwide (US) |
| Quantity | 403,200 tablets |
| Reason classes | specification failure |
| NDC | 27241-0252, 27241-0252-01, 27241-0253, 27241-0253-01, 27241-0254, 27241-0254-01, 27241-0255, 27241-0255-01 |
| Lot numbers | DJ10205, DJ23254 |
| Expiration dates | 2026-11-30, 2027-04-30 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0836-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.