TOPIRAMATE Tablets 200 mg — Class II drug recall D-0015-2015
Terminated recall by Zydus Pharmaceuticals USA Inc, reported 2014-10-22, distributed nationwide. Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets.
| Recall number | D-0015-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zydus Pharmaceuticals USA Inc, Pennington, NJ, United States |
| Recall initiated | 2014-09-15 |
| Classified | 2014-10-10 |
| Reported by FDA | 2014-10-22 |
| Terminated | 2017-09-20 |
| Distributed | Nationwide (US) |
| Quantity | 14,568 bottles |
| NDC | 68382-0138, 68382-0138-01, 68382-0138-05, 68382-0138-14, 68382-0138-16, 68382-0139, 68382-0139-01, 68382-0139-05, 68382-0139-14, 68382-0139-16, 68382-0140, 68382-0140-01, 68382-0140-05, 68382-0140-14, 68382-0140-16, 68382-0141, 68382-0141-01, 68382-0141-05, 68382-0141-14, 68382-0141-16 |
| Lot numbers | MN9828 |
| Expiration dates | 2015-10-20 |
Product
TOPIRAMATE Tablets 200 mg, 60 Tablet Bottles, Rx Only. Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ USA 08534. NDC 68382-141-14.
Reason for recall
Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets.
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-0015-2015. 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.