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

Class I - Dangerous

💊 Drugs Recalled: June 4, 2020 AVKARE Prescription Drugs Nationwide

What Should You Do?

Check if you have this product:
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
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: AVKARE Inc.
Reason for Recall:: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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