Metformin Hydrochloride Extended-Release Tablets — Class II drug recall D-0640-2021
Terminated recall by VIONA PHARMACEUTICALS INC, reported 2021-06-30, distributed nationwide. CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Li
| Recall number | D-0640-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | VIONA PHARMACEUTICALS INC, Cranford, NJ, United States |
| Recall initiated | 2021-06-01 |
| Classified | 2021-06-24 |
| Reported by FDA | 2021-06-30 |
| Terminated | 2023-05-31 |
| Distributed | Nationwide (US) |
| Quantity | 21,240 bottles |
| Reason classes | chemical contamination, cgmp |
| NDC | 72578-0035, 72578-0035-01, 72578-0035-05, 72578-0036, 72578-0036-01, 72578-0036-05 |
| Lot numbers | M915601, M915602 |
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 for recall
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
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-0640-2021. 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.