CLASS II Drug recall · Reported 24 Jun 2020 · FDA Enforcement Report

Metformin Hydrochloride Extended-Release Tablets, USP 750 mg a) recalled

AVKARE is recalling Metformin Hydrochloride Extended-Release Tablets, USP 750 mg a) (, distributed nationwide in the US. The recall was initiated on 4 Jun 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots: a) 23069 Exp. 11/30/2020, 24571 Exp. 05/31/2021, 25310 Exp. 07/31/2021, 26391 Exp. 01/31/2022; b) 22542 Exp. 06/30/2020, 23345 Exp. 11/30/2020, 24032 Exp. 03/31/2021, 24624 Exp. 07/31/2021, 24631 Exp. 05/31/2021, 25381 Exp. 08/31/2021, 25907 Exp. 10/31/2021, 26478 Exp. 01/31/2022; c) 22348 Exp. 06/30/2020, 22405 Exp. 06/30/2020, 22406 Exp. 06/30/2020, 22740 Exp. 06/30/2020, 23346 Exp. 11/30/2020, 23926 Exp. 03/31/2021, 24364 Exp. 05/31/2021, 25014 Exp. 07/31/2021, 25334 Exp. 09/30/2021, 25906 Exp. 10/31/2021, 26392 Exp. 01/31/2022

Quantity recalled88,545 bottles

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-1304-2020
FDA event ID: 85811
Recalling firm: AVKARE, Pulaski, TN
Classification: Class II
Status: Terminated
Recall initiated: 4 Jun 2020
FDA classified: 12 Jun 2020
Reported: 24 Jun 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Nitrosamine Impurity
Drug class: Diabetes Medication

Timeline

4 Jun 2020	Recall initiated by company
12 Jun 2020	Classified by FDA	+8 days
24 Jun 2020	Published in enforcement report	+12 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: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

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 a) 90 count (NDC 42291-611-90) b) 180 count (NDC 42291-611-18) c) 500 count (NDC 42291-611-50) bottles, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478

Where it was distributed

Nationwide.

Nationwide

Questions about this recall

Is Metformin Hydrochloride Extended-Release Tablets, USP 750 mg a) ( recalled?

Yes. AVKARE recalled Metformin Hydrochloride Extended-Release Tablets, USP 750 mg a) ( on 4 Jun 2020. The recall is Class II and its status is Terminated. Recall number D-1304-2020.

Why was it recalled?

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Which lots are affected?

Lots: a) 23069 Exp. 11/30/2020, 24571 Exp. 05/31/2021, 25310 Exp. 07/31/2021, 26391 Exp. 01/31/2022; b) 22542 Exp. 06/30/2020, 23345 Exp. 11/30/2020, 24032 Exp. 03/31/2021, 24624 Exp. 07/31/2021, 24631 Exp. 05/31/2021, 25381 Exp. 08/31/2021, 25907 Exp. 10/31/2021, 26478 Exp. 01/31/2022; c) 22348 Exp. 06/30/2020, 22405 Exp. 06/30/2020, 22406 Exp. 06/30/2020, 22740 Exp. 06/30/2020, 23346 Exp. 11/30/2020, 23926 Exp. 03/31/2021, 24364 Exp. 05/31/2021, 25014 Exp. 07/31/2021, 25334 Exp. 09/30/2021, 25906 Exp. 10/31/2021, 26392 Exp. 01/31/2022

Where was it sold?

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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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Other Metformin recalls

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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