Tiagabine Hydrochloride Tablets — Class II drug recall D-0914-2023
Terminated recall by SUN PHARMACEUTICAL INDUSTRIES INC, reported 2023-07-19, distributed nationwide. Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing
| Recall number | D-0914-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ, United States |
| Recall initiated | 2023-07-10 |
| Classified | 2023-07-11 |
| Reported by FDA | 2023-07-19 |
| Terminated | 2023-12-18 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 62756-0200, 62756-0200-18, 62756-0200-83, 62756-0224, 62756-0224-08, 62756-0224-18, 62756-0224-83, 62756-0224-88 |
| Lot numbers | HAC3339A |
| Expiration dates | 2023-07 |
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 for recall
Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing
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-0914-2023. 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.