Metformin Hydrochloride Extended Release recalls

Metformin Hydrochloride Extended Release products have been recalled 7 times, most recently on 11 Nov 2020. The recalling company is usually PD-Rx Pharmaceuticals. The most common reason is nitrosamine impurity.

Total recalls7since 2020

Last 12 months0reported

Class I00% of total

Ongoing0latest 11 Nov 2020

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 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 7 100%Class III 0 0%

Why metformin hydrochloride extended release is recalled

Nitrosamine Impurity7100%

Companies

Product types

Diabetes Medication7100%

By year

20207100%

All metformin hydrochloride extended release recalls, newest first

7 total

Reported	Class	Recall	Company	Reason	Where
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 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 HCL ER 750 mg 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 recalled by Marksans PharmaMetformin Hydrochloride Extended Release	Marksans Pharma	Nitrosamine Impurity	Nationwide
1 Jul 2020Drug	CLASS II	metFORMIN HCL ER 500 mg, a) recalled by PD-Rx PharmaceuticalsMetformin Hydrochloride Extended Release	PD-Rx Pharmaceuticals	Nitrosamine Impurity	OK
1 Jul 2020Drug	CLASS II	Time-Cap Labs, Inc. Metformin Hydrochloride recalled by Marksans PharmaMetformin Hydrochloride Extended Release	Marksans Pharma	Nitrosamine Impurity	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.