FDA Drug recall D-0914-2023
Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Pharmaceutical Industries
- FDA Drug
- Class II
- terminated
- Published 2023-07-19
On 2023-07-19 the FDA classified a Class II recall of Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Pharmaceutical Industries by Sun Pharmaceutical Industries, citing failed Impurities: Out of Specification (OOS) result observed during Related Substances testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0914-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-07-10 |
| Published | 2023-07-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | US |
Product
Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Pharmaceutical Industries. Inc. Cranbury NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India. NDC#: 62756-200-83
Reason
Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing
Identifiers
| ndc | 62756-200-83 |
|---|---|
| ndc | 62756-200-18 |
| ndc | 62756-224-83 |
| ndc | 62756-224-88 |
| ndc | 62756-224-08 |
| ndc | 62756-224-18 |
| code_info | Lot HAC3339A, Expires 07/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0914-2023%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.