Metformin Hydrochloride Extended-Release Tablets — Class II drug recall D-1303-2020
Completed recall by Apotex Inc., reported 2020-06-24, distributed nationwide. CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels
| Recall number | D-1303-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Apotex Inc., North York, Canada |
| Recall initiated | 2020-05-27 |
| Classified | 2020-06-12 |
| Reported by FDA | 2020-06-24 |
| Distributed | Nationwide (US) |
| Quantity | 305,963 bottles |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 60505-0260-01 |
Product
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 NDC 60505-0260-1
Reason for recall
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels
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-1303-2020. 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.