Metformin recalls

The FDA has published 57 recalls involving Metformin since 2012. The latest was reported on 16 Apr 2025. Most were for nitrosamine impurity. Sun Pharmaceutical Industries has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls57since 2012

Last 12 months0reported

Class I00% of total

Ongoing12latest 16 Apr 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 2Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 53 93%Class III 4 7%

Why metformin is recalled

Companies

Brands

Metformin Hydrochloride2137%
Metformin Hydrochloride Extended Release712%
Riomet35%

By year

202524%
202312%
202212%
2021611%
20203256%
2018611%
201712%
201612%
201512%
201459%

Ongoing metformin recalls

12 active

Reported	Class	Recall	Company	Reason	Where
16 Apr 2025Drug	CLASS II	Metformin Hydrochloride Extended-Release Tablets 1000mg recalledMetformin Hydrochloride	Glenmark Pharmaceuticals Inc., U	Manufacturing (CGMP) Deviations	Nationwide
2 Apr 2025Drug	CLASS II	Metformin Hydrochloride Extended- Release 500mg recalledMetformin Hydrochloride	A-S Medication Solutions	Packaging Defects	Nationwide
10 Feb 2021Drug	CLASS II	Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg recalled	Nostrum Laboratories	Nitrosamine Impurity	Nationwide
20 Jan 2021Drug	CLASS II	Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg recalled	Nostrum Laboratories	Nitrosamine Impurity	Nationwide
11 Nov 2020Drug	CLASS II	Metformin Hydrochloride Extended-Release Tablets USP 750 mg recalled	Denton Pharma	Nitrosamine Impurity	Nationwide
11 Nov 2020Drug	CLASS II	Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) recalled	Denton Pharma	Nitrosamine Impurity	Nationwide

All metformin recalls, newest first

57 total

Reported	Class	Recall	Company	Reason	Where
16 Apr 2025Drug	CLASS II	Metformin Hydrochloride Extended-Release Tablets 1000mg recalledMetformin Hydrochloride	Glenmark Pharmaceuticals Inc., U	Manufacturing (CGMP) Deviations	Nationwide
2 Apr 2025Drug	CLASS II	Metformin Hydrochloride Extended- Release 500mg recalledMetformin Hydrochloride	A-S Medication Solutions	Packaging Defects	Nationwide
15 Mar 2023Drug	CLASS II	Metformin hydrochloride Extended-Release Tablets, 1000 mg recalled	Teva Pharmaceuticals USA	Nitrosamine Impurity	CA
2 Feb 2022Drug	CLASS II	Metformin Hydrochloride Extended-Release Tablets, USP 750 mg HDPE recalledMetformin Hydrochloride	Viona Pharmaceuticals	Nitrosamine Impurity	NJ
30 Jun 2021Drug	CLASS II	Metformin Hydrochloride Extended-Release Tablets, USP 750 mg recalledMetformin Hydrochloride	Viona Pharmaceuticals	Nitrosamine Impurity	Nationwide
19 May 2021Drug	CLASS II	Metformin HCl Extended-Release Tablets, USP, 500 mg recalledMetformin Hydrochloride	Sun Pharmaceutical Industries	Packaging Defects	Nationwide
21 Apr 2021Drug	CLASS II	Riomet (metformin hydrochloride oral solution) 500 mg/ Cherry Flavor recalledRiomet	Sun Pharmaceutical Industries	Sterility	Nationwide
14 Apr 2021Drug	CLASS III	Metformin HCl Extended-Release Tablets, USP, 500 mg recalledMetformin Hydrochloride	Sun Pharmaceutical Industries	Potency & Assay	Nationwide
10 Feb 2021Drug	CLASS II	Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg recalled	Nostrum Laboratories	Nitrosamine Impurity	Nationwide
20 Jan 2021Drug	CLASS II	Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg recalled	Nostrum Laboratories	Nitrosamine Impurity	Nationwide

Should you stop taking Metformin?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.