FDA Drug recall D-0068-2021
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only
- FDA Drug
- Class II
- ongoing
- Published 2020-11-11
On 2020-11-11 the FDA classified a Class II recall of Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only by Nostrum Laboratories, citing CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0068-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-10-23 |
| Published | 2020-11-11 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Nostrum Laboratories |
| Distribution | US |
Product
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-055-01
Reason
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Identifiers
| code_info | MET100201, MET100401 EXP 05/2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0068-2021%22
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