FDA Drug recall D-0836-2026
Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made…
- FDA Drug
- Class III
- ongoing
- Published 2026-09-16
On 2026-09-16 the FDA classified a Class III recall of Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made… by Ajanta Pharma Usa, citing 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….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0836-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2026-08-25 |
| Published | 2026-09-16 |
| Last updated | 2026-09-23 05:30 UTC |
| Company | Ajanta Pharma Usa |
| Distribution | US |
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
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.
Identifiers
| ndc | 27241-255-01 |
|---|---|
| ndc | 27241-254-01 |
| ndc | 27241-253-01 |
| ndc | 27241-252-01 |
| code_info | Lot #: DJ23254, Exp. Date 11/30/2026; DJ10205, Exp. Date 04/30/2027. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-23 05:30 UTC. Current status: ongoing.
Other recalls by Ajanta Pharma Usa
- Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807
FDA Drug · Class II · 2026-10-07 · Ajanta Pharma Usa - Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma Limited, India, Marketed by: Ajanta Pharma USA Inc
FDA Drug · Class II · 2026-07-01 · Ajanta Pharma Usa - Aripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-…
FDA Drug · Class II · 2026-06-24 · Ajanta Pharma Usa
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0836-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.