CLASS II Drug recall · Reported 30 Jun 2021 · FDA Enforcement Report
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg recalled
Viona Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, distributed nationwide in the US. The recall was initiated on 1 Jun 2021 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0640-2021
- FDA event ID
- 88033
- Recalling firm
- Viona Pharmaceuticals, Cranford, NJ
- Manufacturer
- Viona Pharmaceuticals Inc
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Jun 2021
- FDA classified
- 24 Jun 2021
- Reported
- 30 Jun 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Nitrosamine Impurity
- Drug class
- Diabetes Medication
Timeline
| 1 Jun 2021 | Recall initiated by company | |
| 24 Jun 2021 | Classified by FDA | +23 days |
| 30 Jun 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the US
Questions about this recall
Why was it recalled?
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Which lots are affected?
Lot M915601 & M915602, Oct 2021
Where was it sold?
Nationwide in the US
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Viona Pharmaceuticals
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Tavaborole Topical solution recalled by Viona PharmaceuticalsTavaborole | Viona Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Tavaborole Topical Solution recalled by Viona PharmaceuticalsTavaborole | Viona Pharmaceuticals | Foreign Material | Nationwide |
| Drug | CLASS II | Dapsone Gel recalled by Viona PharmaceuticalsDapsone | Viona Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Dapsone Gel recalled by Viona PharmaceuticalsDapsone | Viona Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Dapsone Gel 7.5% pump recalled by Viona PharmaceuticalsDapsone | Viona Pharmaceuticals | Other | Nationwide |
Other Metformin recalls
All 61| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Metformin Hydrochloride Extended-Release Tablets 1000mg recalled | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Metformin Hydrochloride Extended- Release 500mg recalledMetformin Hydrochloride | A-S Medication Solutions | Packaging Defects | Nationwide |
| Drug | CLASS II | Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg recalledMetformin Er 500 Mg | Granules Pharmaceuticals | Other | OH |
| Drug | CLASS II | Metformin hydrochloride Extended-Release Tablets, 1000 mg recalled | Teva Pharmaceuticals USA | Nitrosamine Impurity | CA |
| Drug | CLASS II | Metformin Hydrochloride Extended-Release Tablets, USP 750 mg HDPE recalledMetformin Hydrochloride | Viona Pharmaceuticals | Nitrosamine Impurity | NJ |