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

Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) recalled

AVKARE is recalling Metformin Hydrochloride Extended-Release Tablets, USP 500 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) 23537 Exp. 06/30/2020, 23613 Exp. 06/30/2020, 24083 Exp. 06/30/2020, 24291 Exp. 06/30/2020, 24725 Exp. 06/30/2020, 25637 Exp. 06/30/2021, 25751 Exp. 07/31/2021; b) 22073 Exp. 06/30/2020, 22460 Exp. 07/31/2020, 22539 Exp. 09/30/2020, 22540 Exp. 09/30/2020, 23299 Exp. 01/31/2021, 23300 Exp. 01/31/2021, 23484 Exp. 01/31/2021, 23917 Exp. 03/31/2021, 24477 Exp. 06/30/2021, 24514 Exp. 06/30/2021, 24945 Exp. 08/31/2021, 25591 Exp. 10/31/2021, 25590 Exp. 10/31/2021, 26004 Exp. 11/30/2021, 26322 Exp. 01/31/2021, 26339 Exp. 02/28/2022, 26520 Exp. 01/31/2022, 26588 Exp. 02/28/2022; c) 22202 Exp. 06/30/2020, 22541 Exp. 09/30/2020, 23293 Exp. 01/31/2021, 23475 Exp. 01/31/2021, 23658 Exp. 03/31/2021, 23979 Exp. 03/31/2021, 24303 Exp. 06/30/2021, 24476 Exp. 06/30/2021, 24550 Exp. 06/30/2021, 24804 Exp. 07/31/2021, 25380 Exp. 08/31/2021, 25592 Exp. 10/31/2021, 25736 Exp. 10/31/2021, 26005 Exp. 11/30/2021, 26006 Exp. 10/31/2021, 26326 Exp. 01/31/2022, 26483 Exp. 02/28/2022, 26484 Exp. 02/28/2022,26589 Exp. 02/28/2022; d) 22430 Exp. 06/30/2020, 22538 Exp. 09/30/2020, 22638 Exp. 09/30/2020, 22639 Exp. 09/30/2020, 23292 Exp. 01/31/2021, 23291 Exp. 01/31/2021, 23344 Exp. 01/31/2021, 23631 Exp. 01/31/2021, 23707 Exp. 03/31/2021, 23706 Exp. 03/31/2021, 24164 Exp. 05/31/2021, 24165 Exp. 05/31/2021, 24340 Exp. 06/30/2021, 24474 Exp. 06/30/2021, 24475 Exp. 06/30/2021, 24548 Exp. 06/30/2021, 24738 Exp. 07/31/2021, 24739 Exp. 07/31/2021, 24905 Exp. 07/31/2021, 24906 Exp. 08/31/2021, 25379 Exp. 08/31/2021, 25378 Exp. 08/31/2021, 25627 Exp. 10/31/2021, 25664 Exp. 10/31/2021, 26131 Exp. 01/31/2022, 26340 Exp. 01/31/2022, 26341 Exp. 02/28/2022, 26590 Exp. 02/28/2022, 26591 Exp. 02/28/2022; e) HH01618A Exp. 07/31/2020, HH01718A Exp. 07/31/2020, HH01818A Exp. 07/31/2020, HH01918A Exp. 07/31/2020, HH02018A Exp. 08/31/2020, HH05018A Exp. 08/31/2020, HH05118A Exp. 08/31/2020, HH05218A Exp. 08/31/2020, HH05318A Exp. 08/31/2020, HH05418A Exp. 08/31/2020, HH05518A Exp. 08/31/2020, HH05618A Exp. 08/31/2020, HH05718A Exp. 08/31/2020, HH05818A Exp. 08/31/2020, HH05918A Exp. 08/31/2020, HH06018A Exp. 08/31/2020, HH06118A Exp. 08/31/2020, HH06218A Exp. 08/31/2020, HH06318A Exp. 08/31/2020, HH06418A Exp. 08/31/2020, HK09818A Exp. 10/31/2020, HK09918A Exp. 10/31/2020, HK10018A Exp. 10/31/2020, HK10118A Exp. 10/31/2020, HK10218A Exp. 10/31/2020, HK13618A Exp. 11/30/2020, HB10419A Exp. 03/31/2021, HC00119A Exp. 03/31/2021, HC00219A Exp. 03/31/2021, HC00319A Exp. 03/31/2021, HC00419A Exp. 03/31/2021, HD01619A Exp. 04/30/2021, HD01719A Exp. 04/30/2021, HD01819A Exp. 04/30/2021, HD01919A Exp. 04/30/2021, HD02019A Exp. 04/30/2021, HD09319B Exp. 04/30/2021, HD09419A Exp. 04/30/2021, HD09519A Exp. 04/30/2021, HD09619A Exp. 04/30/2021, HD09719A Exp. 04/30/2021, HD09819A Exp. 04/30/2021, HD09919A Exp. 04/30/2021, HE00919A Exp. 04/30/2021, HE01019A Exp. 04/30/2021, HE01119A Exp. 04/30/2021, HE09419A Exp. 05/31/2021, HE09519A Exp. 05/31/2021, HE13119A Exp. 05/31/2021, HE13219A Exp. 05/31/2021, HE13319A Exp. 05/31/2021, HE13419A Exp. 05/31/2021, HE13519A Exp. 05/31/2021, HE13619A Exp. 05/31/2021, HE13719A Exp. 05/31/2021, HE13819A Exp. 05/31/2021, HE13919A Exp. 05/31/2021, HE14019A Exp. 05/31/2021, HF01919A Exp. 05/31/2021, HF02019A Exp. 05/31/2021, HF02119A Exp. 05/31/2021, HG06019A Exp. 07/31/2021, HG06119A Exp. 07/31/2021, HG06219A Exp. 07/31/2021, HG06319A Exp. 07/31/2021, HG06419A Exp. 07/31/2021, HG06519A Exp. 07/31/2021, HG06619A Exp. 07/31/2021, HG06719A Exp. 07/31/2021, HG06819A Exp. 07/31/2021, HG06919A Exp. 07/31/2021, HH03419A Exp. 08/31/2021, HH03519A Exp. 08/31/2021, HH03619A Exp. 08/31/2021, HH03719A Exp. 08/31/2021, HH03819A Exp. 08/31/2021, HH03919A Exp. 08/31/2021, HH04019A Exp. 08/31/2021, HH04119A Exp. 08/31/2021, HH04219A Exp. 08/31/2021, HH04319A Exp. 08/31/2021, HH08319A Exp. 08/31/2021, HH08419A Exp. 08/31/2021, HH08519A Exp. 08/31/2021, HH08619A Exp. 08/31/2021, HH08719A Exp. 08/31/2021, HH08819A Exp. 08/31/2021, HH08919A Exp. 08/31/2021, HH09019A Exp. 08/31/2021, HH09119A Exp. 08/31/2021, HH09219A Exp. 08/31/2021, HL01119B Exp. 11/30/2021, HL01219A Exp. 11/30/2021, HA00520A Exp. 01/31/2022, HA00620A Exp. 01/31/2022, HA00720A Exp. 01/31/2022, HA00820A Exp. 01/31/2022, HA00920A Exp. 01/31/2022, HA01020A Exp. 01/31/2022, HA01120A Exp. 01/31/2022, HA01220A Exp. 01/31/2022, HB05720A Exp. 02/28/2022, HB05820A Exp. 02/28/2022, HB05920A Exp. 02/28/2022, HB06020A Exp. 02/28/2022, HB06120A Exp. 02/28/2022, HB06220A Exp. 02/28/2022, HB06320A Exp. 02/28/2022, HB06420A Exp. 02/28/2022, HB06520A Exp. 02/28/2022, HB06620A Exp. 02/28/2022

Quantity recalled1,586,913 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-1305-2020
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 500 mg, a) 50 count (NDC 50268-531-15); b) 90 count (NDC 42291-610-90); c) 180 count (NDC 42291-610-18); d) 360 count (NDC 42291-610-36); e) 1000 count (NDC 42291-610-10) 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 500 mg, a) ( recalled?

Yes. AVKARE recalled Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) ( on 4 Jun 2020. The recall is Class II and its status is Terminated. Recall number D-1305-2020.

Why was it recalled?

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

Which lots are affected?

Lots: a) 23537 Exp. 06/30/2020, 23613 Exp. 06/30/2020, 24083 Exp. 06/30/2020, 24291 Exp. 06/30/2020, 24725 Exp. 06/30/2020, 25637 Exp. 06/30/2021, 25751 Exp. 07/31/2021; b) 22073 Exp. 06/30/2020, 22460 Exp. 07/31/2020, 22539 Exp. 09/30/2020, 22540 Exp. 09/30/2020, 23299 Exp. 01/31/2021, 23300 Exp. 01/31/2021, 23484 Exp. 01/31/2021, 23917 Exp. 03/31/2021, 24477 Exp. 06/30/2021, 24514 Exp. 06/30/2021, 24945 Exp. 08/31/2021, 25591 Exp. 10/31/2021, 25590 Exp. 10/31/2021, 26004 Exp. 11/30/2021, 26322 Exp. 01/31/2021, 26339 Exp. 02/28/2022, 26520 Exp. 01/31/2022, 26588 Exp. 02/28/2022; c) 22202 Exp. 06/30/2020, 22541 Exp. 09/30/2020, 23293 Exp. 01/31/2021, 23475 Exp. 01/31/2021, 23658 Exp. 03/31/2021, 23979 Exp. 03/31/2021, 24303 Exp. 06/30/2021, 24476 Exp. 06/30/2021, 24550 Exp. 06/30/2021, 24804 Exp. 07/31/2021, 25380 Exp. 08/31/2021, 25592 Exp. 10/31/2021, 25736 Exp. 10/31/2021, 26005 Exp. 11/30/2021, 26006 Exp. 10/31/2021, 26326 Exp. 01/31/2022, 26483 Exp. 02/28/2022, 26484 Exp. 02/28/2022,26589 Exp. 02/28/2022; d) 22430 Exp. 06/30/2020, 22538 Exp. 09/30/2020, 22638 Exp. 09/30/2020, 22639 Exp. 09/30/2020, 23292 Exp. 01/31/2021, 23291 Exp. 01/31/2021, 23344 Exp. 01/31/2021, 23631 Exp. 01/31/2021, 23707 Exp. 03/31/2021, 23706 Exp. 03/31/2021, 24164 Exp. 05/31/2021, 24165 Exp. 05/31/2021, 24340 Exp. 06/30/2021, 24474 Exp. 06/30/2021, 24475 Exp. 06/30/2021, 24548 Exp. 06/30/2021, 24738 Exp. 07/31/2021, 24739 Exp. 07/31/2021, 24905 Exp. 07/31/2021, 24906 Exp. 08/31/2021, 25379 Exp. 08/31/2021, 25378 Exp. 08/31/2021, 25627 Exp. 10/31/2021, 25664 Exp. 10/31/2021, 26131 Exp. 01/31/2022, 26340 Exp. 01/31/2022, 26341 Exp. 02/28/2022, 26590 Exp. 02/28/2022, 26591 Exp. 02/28/2022; e) HH01618A Exp. 07/31/2020, HH01718A Exp. 07/31/2020, HH01818A Exp. 07/31/2020, HH01918A Exp. 07/31/2020, HH02018A Exp. 08/31/2020, HH05018A Exp. 08/31/2020, HH05118A Exp. 08/31/2020, HH05218A Exp. 08/31/2020, HH05318A Exp. 08/31/2020, HH05418A Exp. 08/31/2020, HH05518A Exp. 08/31/2020, HH05618A Exp. 08/31/2020, HH05718A Exp. 08/31/2020, HH05818A Exp. 08/31/2020, HH05918A Exp. 08/31/2020, HH06018A Exp. 08/31/2020, HH06118A Exp. 08/31/2020, HH06218A Exp. 08/31/2020, HH06318A Exp. 08/31/2020, HH06418A Exp. 08/31/2020, HK09818A Exp. 10/31/2020, HK09918A Exp. 10/31/2020, HK10018A Exp. 10/31/2020, HK10118A Exp. 10/31/2020, HK10218A Exp. 10/31/2020, HK13618A Exp. 11/30/2020, HB10419A Exp. 03/31/2021, HC00119A Exp. 03/31/2021, HC00219A Exp. 03/31/2021, HC00319A Exp. 03/31/2021, HC00419A Exp. 03/31/2021, HD01619A Exp. 04/30/2021, HD01719A Exp. 04/30/2021, HD01819A Exp. 04/30/2021, HD01919A Exp. 04/30/2021, HD02019A Exp. 04/30/2021, HD09319B Exp. 04/30/2021, HD09419A Exp. 04/30/2021, HD09519A Exp. 04/30/2021, HD09619A Exp. 04/30/2021, HD09719A Exp. 04/30/2021, HD09819A Exp. 04/30/2021, HD09919A Exp. 04/30/2021, HE00919A Exp. 04/30/2021, HE01019A Exp. 04/30/2021, HE01119A Exp. 04/30/2021, HE09419A Exp. 05/31/2021, HE09519A Exp. 05/31/2021, HE13119A Exp. 05/31/2021, HE13219A Exp. 05/31/2021, HE13319A Exp. 05/31/2021, HE13419A Exp. 05/31/2021, HE13519A Exp. 05/31/2021, HE13619A Exp. 05/31/2021, HE13719A Exp. 05/31/2021, HE13819A Exp. 05/31/2021, HE13919A Exp. 05/31/2021, HE14019A Exp. 05/31/2021, HF01919A Exp. 05/31/2021, HF02019A Exp. 05/31/2021, HF02119A Exp. 05/31/2021, HG06019A Exp. 07/31/2021, HG06119A Exp. 07/31/2021, HG06219A Exp. 07/31/2021, HG06319A Exp. 07/31/2021, HG06419A Exp. 07/31/2021, HG06519A Exp. 07/31/2021, HG06619A Exp. 07/31/2021, HG06719A Exp. 07/31/2021, HG06819A Exp. 07/31/2021, HG06919A Exp. 07/31/2021, HH03419A Exp. 08/31/2021, HH03519A Exp. 08/31/2021, HH03619A Exp. 08/31/2021, HH03719A Exp. 08/31/2021, HH03819A Exp. 08/31/2021, HH03919A Exp. 08/31/2021, HH04019A Exp. 08/31/2021, HH04119A Exp. 08/31/2021, HH04219A Exp. 08/31/2021, HH04319A Exp. 08/31/2021, HH08319A Exp. 08/31/2021, HH08419A Exp. 08/31/2021, HH08519A Exp. 08/31/2021, HH08619A Exp. 08/31/2021, HH08719A Exp. 08/31/2021, HH08819A Exp. 08/31/2021, HH08919A Exp. 08/31/2021, HH09019A Exp. 08/31/2021, HH09119A Exp. 08/31/2021, HH09219A Exp. 08/31/2021, HL01119B Exp. 11/30/2021, HL01219A Exp. 11/30/2021, HA00520A Exp. 01/31/2022, HA00620A Exp. 01/31/2022, HA00720A Exp. 01/31/2022, HA00820A Exp. 01/31/2022, HA00920A Exp. 01/31/2022, HA01020A Exp. 01/31/2022, HA01120A Exp. 01/31/2022, HA01220A Exp. 01/31/2022, HB05720A Exp. 02/28/2022, HB05820A Exp. 02/28/2022, HB05920A Exp. 02/28/2022, HB06020A Exp. 02/28/2022, HB06120A Exp. 02/28/2022, HB06220A Exp. 02/28/2022, HB06320A Exp. 02/28/2022, HB06420A Exp. 02/28/2022, HB06520A Exp. 02/28/2022, HB06620A Exp. 02/28/2022

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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