Metformin Hydrochloride recalls

Metformin Hydrochloride products have been recalled 16 times, most recently on 16 Apr 2025. The recalling company is usually Amneal Pharmaceuticals of New York. The most common reason is nitrosamine impurity.

Total recalls16since 2014

Last 12 months0reported

Class I00% of total

Ongoing6latest 16 Apr 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 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 0 0%Class II 14 88%Class III 2 13%

Why metformin hydrochloride is recalled

Companies

Product types

Diabetes Medication16100%

By year

2025213%
202216%
2021319%
2020638%
2018213%
201616%
201416%

Ongoing metformin hydrochloride recalls

6 active

Reported	Class	Recall	Company	Reason	Where
16 Apr 2025Drug	CLASS II	Metformin Hydrochloride Extended-Release Tablets 1000mg recalledMetformin Hydrochloride	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
1 Jul 2020Drug	CLASS II	amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg recalledMetformin Hydrochloride	Amneal Pharmaceuticals of New York	Nitrosamine Impurity	Nationwide
1 Jul 2020Drug	CLASS II	amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg recalledMetformin Hydrochloride	Amneal Pharmaceuticals of New York	Nitrosamine Impurity	Nationwide
1 Jul 2020Drug	CLASS II	amneal Metformin Hydrochloride Extended-release Tablets, USP 500 mg recalledMetformin Hydrochloride	Amneal Pharmaceuticals of New York	Nitrosamine Impurity	Nationwide
1 Jul 2020Drug	CLASS II	amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg recalledMetformin Hydrochloride	Amneal Pharmaceuticals of New York	Nitrosamine Impurity	Nationwide

All metformin hydrochloride recalls, newest first

16 total

Reported	Class	Recall	Company	Reason	Where
16 Apr 2025Drug	CLASS II	Metformin Hydrochloride Extended-Release Tablets 1000mg recalledMetformin Hydrochloride	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
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
14 Apr 2021Drug	CLASS III	Metformin HCl Extended-Release Tablets, USP, 500 mg recalledMetformin Hydrochloride	SUN Pharmaceutical Industries	Potency & Assay	Nationwide
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
1 Jul 2020Drug	CLASS II	amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg recalledMetformin Hydrochloride	Amneal Pharmaceuticals of New York	Nitrosamine Impurity	Nationwide
1 Jul 2020Drug	CLASS II	amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg recalledMetformin Hydrochloride	Amneal Pharmaceuticals of New York	Nitrosamine Impurity	Nationwide
1 Jul 2020Drug	CLASS II	amneal Metformin Hydrochloride Extended-release Tablets, USP 500 mg recalledMetformin Hydrochloride	Amneal Pharmaceuticals of New York	Nitrosamine Impurity	Nationwide
1 Jul 2020Drug	CLASS II	amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg recalledMetformin Hydrochloride	Amneal Pharmaceuticals of New York	Nitrosamine Impurity	Nationwide
25 Jul 2018Drug	CLASS II	Metformin Hydrochloride Extended Release Tablets, USP, 500 mg recalledMetformin Hydrochloride	Sun Pharmaceutical Industries	Foreign Material	AZ
28 Feb 2018Drug	CLASS III	Metformin Hydrochloride Tablets, USP 1000 mg recalledMetformin Hydrochloride	Aurobindo Pharma	Other	Nationwide
7 Dec 2016Drug	CLASS II	Metformin Hydrochloride Tablets, USP 500 mg recalledMetformin Hydrochloride	Ascend Laboratories	Other	5 states
5 Mar 2014Drug	CLASS II	Metformin HCl Extended-Release Tablets, USP, 500 mg recalledMetformin Hydrochloride	Caraco Pharmaceutical Laboratories	Other	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.