Topiramate Tablets — Class III drug recall D-0255-2022
Terminated recall by UNICHEM PHARMACEUTICALS USA INC, reported 2021-12-01, distributed nationwide. Discoloration
| Recall number | D-0255-2022 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | UNICHEM PHARMACEUTICALS USA INC, East Brunswick, NJ, United States |
| Recall initiated | 2021-10-25 |
| Classified | 2021-11-19 |
| Reported by FDA | 2021-12-01 |
| Terminated | 2022-10-12 |
| Distributed | Nationwide (US) |
| Quantity | 1,284 bottles |
| NDC | 29300-0115, 29300-0115-01, 29300-0115-05, 29300-0115-10, 29300-0115-16, 29300-0116, 29300-0116-01, 29300-0116-05, 29300-0116-10, 29300-0116-16, 29300-0117, 29300-0117-01, 29300-0117-05, 29300-0117-10, 29300-0117-16, 29300-0118, 29300-0118-01, 29300-0118-05, 29300-0118-10, 29300-0118-16 |
| Lot numbers | ZTPM20044 |
| Expiration dates | 2022-09-30 |
Product
Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: Unichem Laboratories LTD, Ind. Area. Meerut Road, Ghaziabad -201 003, India. Manufactured for: Unichem Pharmaceuticals (USA), Inc., East Brunswick, NJ 06815, NDC 29300-116-05.
Reason for recall
Discoloration
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-0255-2022. 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.