Topiramate Tablets — Class III drug recall D-1645-2012
Terminated recall by American Health Packaging, reported 2012-08-22, distributed nationwide. Labeling: Label Mix-Up: A typographical error in the product form on the carton label incorrectly lists the co
| Recall number | D-1645-2012 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Health Packaging, Columbus, OH, United States |
| Recall initiated | 2012-07-25 |
| Classified | 2012-08-14 |
| Reported by FDA | 2012-08-22 |
| Terminated | 2013-07-02 |
| Distributed | Nationwide (US) |
| Quantity | 1,170 cartons |
| Reason classes | labeling |
| NDC | 68084-0343-21 |
| Lot numbers | 04/13, 113032A, 113032B |
Product
Topiramate Tablets, 50 mg, 30-count (3 x 10) unit-dose blisters per carton, Rx only, Mfd by: Cadila Healthcare Ltd., Ahmedabad, India; Dist By: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534, Pkg by: American Health Packaging, Col. OH 43217, NDC 68084-343-21, blister barcode 6808434311
Reason for recall
Labeling: Label Mix-Up: A typographical error in the product form on the carton label incorrectly lists the configuration as 30 "Capsules" (3 x 10) rather than "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-1645-2012. 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.