FDA Drug recall D-1303-2020
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only Manufactured by: Apotex, Inc
- FDA Drug
- Class II
- completed
- Published 2020-06-24
On 2020-06-24 the FDA classified a Class II recall of Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only Manufactured by: Apotex, Inc by Apotex, citing CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1303-2020 |
| Classification | Class II |
| Status | completed |
| Initiated | 2020-05-27 |
| Published | 2020-06-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Apotex |
| Distribution | US |
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
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels
Identifiers
| code_info | All lots remaining within expiry |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1303-2020%22
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