CLASS II ONGOING Drug recall · Reported 11 Nov 2020 · FDA Enforcement Report

Metformin Hydrochloride Extended-Release Tablets USP 750 mg recalled

Denton Pharma is recalling Metformin Hydrochloride Extended-Release Tablets USP 750 mg, distributed nationwide in the US. The recall was initiated on 8 Oct 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesN107411901, N107411903, N107411904, N107411905, N107411906, exp 11/30/2020; N107411907, N107412001, exp 4/30/2021; N107412002, N107412004, exp 11/30/2021; N107412003, exp 7/31/2021

Quantity recalledN/A

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-0056-2021
FDA event ID: 86593
Recalling firm: Denton Pharma, North Blenheim, NY
Classification: Class II
Status: Ongoing
Recall initiated: 8 Oct 2020
FDA classified: 2 Nov 2020
Reported: 11 Nov 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Nitrosamine Impurity
Drug class: Diabetes Medication

Timeline

8 Oct 2020	Recall initiated by company
2 Nov 2020	Classified by FDA	+25 days
11 Nov 2020	Published in enforcement report	+9 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 (per manufacturer)

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, 30 Tablets bottle, Rx Only, Time-Cap Labs, Inc., Repackaged By: Northwind Pharmaceuticals North Blenheim NY 12131 NDC 70934-334-30

Where it was distributed

Indiana - Nationwide.

Nationwide Indiana

Questions about this recall

Why was it recalled?

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)

Which lots are affected?

N107411901, N107411903, N107411904, N107411905, N107411906, exp 11/30/2020; N107411907, N107412001, exp 4/30/2021; N107412002, N107412004, exp 11/30/2021; N107412003, exp 7/31/2021

Where was it sold?

Indiana - 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.

Other products in this recall event

1 other product · FDA event 86593

This product is part of a recall event; the main page for the event is Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) recalled.

Reported	Class	Recall	Company	Reason	Where
11 Nov 2020	CLASS II	Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) recalled	Denton Pharma	Nitrosamine Impurity	Nationwide

More recalls from Denton Pharma

All 4

Reported	Class	Recall	Company	Reason	Where
11 Nov 2020Drug	CLASS II	Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) recalled	Denton Pharma	Nitrosamine Impurity	Nationwide
29 Jan 2020Drug	CLASS II	Ranitidine Tablets, USP 300 mg a) recalled by Denton Pharma	Denton Pharma	Nitrosamine Impurity	Nationwide
29 Jan 2020Drug	CLASS II	Ranitidine Tablets, USP 150 mg , a) recalled by Denton Pharma	Denton Pharma	Nitrosamine Impurity	Nationwide

Other Metformin recalls

All 58

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