FDA Drug recall D-0255-2022
Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: Unichem Laboratories LTD, Ind
- FDA Drug
- Class III
- terminated
- Published 2021-12-01
On 2021-12-01 the FDA classified a Class III recall of Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: Unichem Laboratories LTD, Ind by Unichem Pharmaceuticals Usa, citing discoloration.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0255-2022 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-10-25 |
| Published | 2021-12-01 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Unichem Pharmaceuticals Usa |
| Distribution | US |
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
Discoloration
Identifiers
| ndc | 29300-115-16 |
|---|---|
| ndc | 29300-115-01 |
| ndc | 29300-115-05 |
| ndc | 29300-115-10 |
| ndc | 29300-116-16 |
| ndc | 29300-116-01 |
| ndc | 29300-116-05 |
| ndc | 29300-116-10 |
| ndc | 29300-117-16 |
| ndc | 29300-117-01 |
| ndc | 29300-117-05 |
| ndc | 29300-117-10 |
| ndc | 29300-118-16 |
| ndc | 29300-118-01 |
| ndc | 29300-118-05 |
| ndc | 29300-118-10 |
| code_info | Lot #: ZTPM20044, Exp. Date 09/30/2022 |
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-0255-2022%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.