Warfarin Sodium Tablets — Class I drug recall D-838-2013
Terminated recall by Zydus Pharmaceuticals USA Inc, reported 2013-08-14, distributed nationwide. Failed Tablet/Capsule Specifications: A product complaint was received from a pharmacist who discovered that 3
| Recall number | D-838-2013 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zydus Pharmaceuticals USA Inc, Pennington, NJ, United States |
| Recall initiated | 2013-05-13 |
| Classified | 2013-08-02 |
| Reported by FDA | 2013-08-14 |
| Terminated | 2015-05-05 |
| Distributed | Nationwide (US) |
| Quantity | 960 bottles |
| NDC | 68382-0053-10 |
| Lot numbers | MM5767 |
Product
Warfarin Sodium Tablets, USP 2 mg, Rx Only, 1000 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-053-10
Reason for recall
Failed Tablet/Capsule Specifications: A product complaint was received from a pharmacist who discovered that 3 tablets in a 1000-count bottle were oversized.
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-838-2013. 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.