Metformin Hydrochloride Tablets — Class II drug recall D-1428-2012
Terminated recall by Zydus Pharmaceuticals USA Inc, reported 2012-08-08, distributed nationwide. Presence of Foreign Substance(s): A product complaint was received from a pharmacist who discovered that sever
| Recall number | D-1428-2012 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zydus Pharmaceuticals USA Inc, Pennington, NJ, United States |
| Recall initiated | 2012-03-14 |
| Classified | 2012-07-27 |
| Reported by FDA | 2012-08-08 |
| Terminated | 2013-12-17 |
| Distributed | Nationwide (US) |
| Quantity | 1,176 bottles |
| Reason classes | foreign material |
| NDC | 68382-0030-10 |
| Lot numbers | ML9605 |
| Expiration dates | 2013-10 |
Product
Metformin Hydrochloride Tablets, USP, 1000 mg, Rx only, 1000 count tablets per Bottle, Manufactured by: Cadila Healthcare LTD. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534, NDC 68382-030-10.
Reason for recall
Presence of Foreign Substance(s): A product complaint was received from a pharmacist who discovered that several tablets displayed brown specks. The same complainant also reported that metal shaving like material was observed on the surface of one tablet.
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-1428-2012. 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.