CLASS II Drug recall · Reported 1 Jul 2020 · FDA Enforcement Report
Metformin Hydrochloride Extended-Release Tablets recalled
Teva Pharmaceuticals U is recalling Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, a) 100 (, distributed nationwide in the US. The recall was initiated on 2 Jun 2020 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-1332-2020
- FDA event ID
- 85797
- Recalling firm
- Teva Pharmaceuticals U, Parsippany, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Jun 2020
- FDA classified
- 19 Jun 2020
- Reported
- 1 Jul 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Nitrosamine Impurity
- Drug class
- Diabetes Medication
Timeline
| 2 Jun 2020 | Recall initiated by company | |
| 19 Jun 2020 | Classified by FDA | +17 days |
| 1 Jul 2020 | 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: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
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, a) 100 (NDC 62037-577-01) and b) 1000 (NDC 62037-577-10), Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa, Distributed by: Actavis Pharma, Inc., Parsippany, NJ
Where it was distributed
Product was distributed throughout the United States, including Puerto Rico.
Questions about this recall
Is Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, a) 100 ( recalled?
Yes. Teva Pharmaceuticals U recalled Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, a) 100 ( on 2 Jun 2020. The recall is Class II and its status is Terminated. Recall number D-1332-2020.
Why was it recalled?
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Which lots are affected?
a) 1333338M, exp. date 08/2020, 1333339A, exp. date 08/2020; b) 1354471A, exp. date 02/2021
Where was it sold?
Product was distributed throughout the United States, including Puerto Rico.
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.
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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 HDPE recalledMetformin Hydrochloride | Viona Pharmaceuticals | Nitrosamine Impurity | NJ |
| Drug | CLASS II | Metformin Hydrochloride Extended-Release Tablets, USP 750 mg recalledMetformin Hydrochloride | Viona Pharmaceuticals | Nitrosamine Impurity | Nationwide |