FDA Drug recall D-0640-2021
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 Tablets, Rx only, Manufactured by: Cadila Healthcare Ltd
- FDA Drug
- Class II
- terminated
- Published 2021-06-30
On 2021-06-30 the FDA classified a Class II recall of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 Tablets, Rx only, Manufactured by: Cadila Healthcare Ltd by Viona Pharmaceuticals, citing CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0640-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-06-01 |
| Published | 2021-06-30 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Viona Pharmaceuticals |
| Distribution | US |
Product
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 Tablets, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. Distributed by: Viona Pharmaceuticals Inc. Cranford, NJ 07016 NDC 72578-036-01
Reason
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Identifiers
| ndc | 72578-035-01 |
|---|---|
| ndc | 72578-035-05 |
| ndc | 72578-036-01 |
| ndc | 72578-036-05 |
| code_info | Lot M915601 & M915602, Oct 2021 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0640-2021%22
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