CLASS II Drug recall · Reported 2 Feb 2022 · FDA Enforcement Report
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg HDPE recalled
Viona Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets, USP 750 mg HDPE. The recall was initiated on 27 Dec 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-0392-2022
- FDA event ID
- 89305
- Recalling firm
- Viona Pharmaceuticals, Cranford, NJ
- Manufacturer
- Viona Pharmaceuticals Inc
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Dec 2021
- FDA classified
- 21 Jan 2022
- Reported
- 2 Feb 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Nitrosamine Impurity
- Drug class
- Diabetes Medication
Timeline
| 27 Dec 2021 | Recall initiated by company | |
| 21 Jan 2022 | Classified by FDA | +25 days |
| 2 Feb 2022 | Published in enforcement report | +12 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 count HDPE bottles NDC# 72578-036-01
Where it was distributed
Product was distributed to 17 wholesalers who further distributed the product to 85 locations.
Questions about this recall
Is Metformin Hydrochloride Extended-Release Tablets, USP 750 mg HDPE recalled?
Yes. Viona Pharmaceuticals recalled Metformin Hydrochloride Extended-Release Tablets, USP 750 mg HDPE on 27 Dec 2021. The recall is Class II and its status is Terminated. Recall number D-0392-2022.
Why was it recalled?
CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Which lots are affected?
M008130 06/2022, M008131 06/2022, M008132 06/2022, M008133 06/2022, M010080 07/2022, M010081 07/2022, M011029 08/2022, M011030 08/2022, M011031 08/2022, M011032 08/2022, M011304 08/2022, M013394 09/2022, M013395 09/2022, M013396 09/2022, M013966 09/2022, M013967 09/2022, M100831 12/2022, M100832 12/2022, M100833 01/2023, M100834 01/2023, M101267 01/2023, M102718 01/2023, M102719 01/2023
Where was it sold?
Product was distributed to 17 wholesalers who further distributed the product to 85 locations.
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 21 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 5% pump recalled by Viona PharmaceuticalsDapsone | Viona Pharmaceuticals | Other | Nationwide |
Other Metformin recalls
All 57| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Metformin Hydrochloride Extended-Release Tablets 1000mg recalledMetformin Hydrochloride | Glenmark Pharmaceuticals Inc., U | 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, 1000 mg recalled | Teva Pharmaceuticals USA | Nitrosamine Impurity | CA |
| Drug | CLASS II | Metformin Hydrochloride Extended-Release Tablets, USP 750 mg recalledMetformin Hydrochloride | Viona Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Metformin HCl Extended-Release Tablets, USP, 500 mg recalledMetformin Hydrochloride | Sun Pharmaceutical Industries | Packaging Defects | Nationwide |