CLASS II ONGOING Drug recall · Reported 10 Feb 2021 · FDA Enforcement Report
Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg recalled
Nostrum Laboratories is recalling Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg per, distributed nationwide in the US. The recall was initiated on 25 Jan 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-0249-2021
- FDA event ID
- 87210
- Recalling firm
- Nostrum Laboratories, Kansas City, MO
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Jan 2021
- FDA classified
- 4 Feb 2021
- Reported
- 10 Feb 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Nitrosamine Impurity
- Drug class
- Diabetes Medication
Timeline
| 25 Jan 2021 | Recall initiated by company | |
| 4 Feb 2021 | Classified by FDA | +10 days |
| 10 Feb 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) 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, 100 Tablets per bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120. NDC: 29033-056-01
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.
Which lots are affected?
Lot MET200601, 07/2022
Where was it sold?
Nationwide
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 Nostrum Laboratories
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sucralfate Tablets recalled by Nostrum Laboratories | Nostrum Laboratories | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg recalled | Nostrum Laboratories | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Metformin Hydrochloride Extended-Release Tablets, USP 750 mg recalled | Nostrum Laboratories | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Metformin Hydrochloride Extended-Release Tablets, USP 500 mg recalled | Nostrum Laboratories | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Theophylline (Anhydrous) Extended-Release Tablets, 400 mg recalled | Nostrum Laboratories | Labeling Errors | MO, TN |
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 |