Metformin recalls

The FDA has published 61 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 recalls61since 2012

Last 12 months0reported

Class I12% of total

Ongoing14latest 16 Apr 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 1 0Feb 0 2 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 1 2%Class II 56 92%Class III 4 7%

Why metformin is recalled

Companies

Brands

Metformin Hydrochloride1525%
Metformin Hydrochloride Extended Release711%
Riomet35%
Metformin Er 500 Mg12%
Metformin12%

By year

202535%
202312%
202223%
2021711%
20203252%
2018610%
201712%
201612%
201512%
2014610%

Ongoing metformin recalls

14 active

Reported	Class	Recall	Company	Reason	Where
16 Apr 2025Drug	CLASS II	Metformin Hydrochloride Extended-Release Tablets 1000mg recalled	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
2 Apr 2025Drug	CLASS II	Metformin Hydrochloride Extended- Release 500mg recalledMetformin Hydrochloride	A-S Medication Solutions	Packaging Defects	Nationwide
26 May 2021Drug	CLASS II	Metformin HCl, Extended Release Tab recalled	Preferred Pharmaceuticals	Nitrosamine Impurity	FL
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

All metformin recalls, newest first

61 total

Reported	Class	Recall	Company	Reason	Where
16 Apr 2025Drug	CLASS II	Metformin Hydrochloride Extended-Release Tablets 1000mg recalled	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
2 Apr 2025Drug	CLASS II	Metformin Hydrochloride Extended- Release 500mg recalledMetformin Hydrochloride	A-S Medication Solutions	Packaging Defects	Nationwide
15 Jan 2025Drug	CLASS II	Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg recalledMetformin Er 500 Mg	Granules Pharmaceuticals	Other	OH
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
19 Jan 2022Drug	CLASS II	Metformin 750 mg Extended Release recalled by RemedyRepack	RemedyRepack	Nitrosamine Impurity	PA
30 Jun 2021Drug	CLASS II	Metformin Hydrochloride Extended-Release Tablets, USP 750 mg recalledMetformin Hydrochloride	Viona Pharmaceuticals	Nitrosamine Impurity	Nationwide
26 May 2021Drug	CLASS II	Metformin HCl, Extended Release Tab recalled	Preferred Pharmaceuticals	Nitrosamine Impurity	FL
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
25 Nov 2020Drug	CLASS II	Metformin HCl Extended Release Tablets USP 500 mg recalled	Preferred Pharmaceuticals	Nitrosamine Impurity	FL
11 Nov 2020Drug	CLASS II	Metformin HCL E/R 500 mg, 90 Tabs, Packaged recalled by Direct RxMetformin Hydrochloride Extended Release	Direct Rx	Nitrosamine Impurity	FL
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 HCL ER 500 mg, a) recalled by PD-Rx PharmaceuticalsMetformin Hydrochloride Extended Release	PD-Rx Pharmaceuticals	Nitrosamine Impurity	16 states
11 Nov 2020Drug	CLASS II	Time-Cap Labs, Inc. Metformin Hydrochloride Extended recalledMetformin Hydrochloride Extended Release	Marksans Pharma	Nitrosamine Impurity	Nationwide
11 Nov 2020Drug	CLASS II	Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) recalled	Denton Pharma	Nitrosamine Impurity	Nationwide
11 Nov 2020Drug	CLASS II	Metformin Hydrochloride Extended-Release Tablets, USP 750 mg recalled	Nostrum Laboratories	Nitrosamine Impurity	Nationwide
11 Nov 2020Drug	CLASS II	metformin HCL ER 750 mg recalled by PD-Rx PharmaceuticalsMetformin Hydrochloride Extended Release	PD-Rx Pharmaceuticals	Nitrosamine Impurity	16 states
11 Nov 2020Drug	CLASS II	Metformin Hydrochloride Extended-Release Tablets, USP 500 mg recalled	Nostrum Laboratories	Nitrosamine Impurity	Nationwide
11 Nov 2020Drug	CLASS II	Time-Cap Labs, Inc. Metformin Hydrochloride recalled by Marksans PharmaMetformin Hydrochloride Extended Release	Marksans Pharma	Nitrosamine Impurity	Nationwide
7 Oct 2020Drug	CLASS III	Metformin Hydrochloride Tablets USP, 1000 mg recalled	Legacy Pharmaceutical Packaging	Packaging Defects	AR, GA
2 Sep 2020Drug	CLASS II	Metformin Hydrochloride Extended-Release Tablets USP, 500 mg recalledMetformin Hydrochloride	Bayshore Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
2 Sep 2020Drug	CLASS II	Metformin Hydrochloride Extended-Release Tablets USP, 750 mg recalledMetformin Hydrochloride	Bayshore Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
22 Jul 2020Drug	CLASS II	Metformin Hydrochloride Extended-Release Tablets USP 1000 mg recalled	Lupin Pharmaceuticals	Nitrosamine Impurity	Nationwide
22 Jul 2020Drug	CLASS II	Metformin Hydrochloride Extended-Release Tablets USP 500 mg recalled	Lupin Pharmaceuticals	Nitrosamine Impurity	Nationwide
22 Jul 2020Drug	CLASS II	Metformin Hydrochloride Extended-Release Tablets USP 1000 mg recalled	Lupin Pharmaceuticals	Nitrosamine Impurity	Nationwide
22 Jul 2020Drug	CLASS II	Metformin Hydrochloride Extended-Release Tablets recalledMetformin	Granules Pharmaceuticals	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.