Drug recall · FDA · Published June 4, 2020

AVKARE Inc. recalls Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 50 count (NDC 50268-531-15); b) 90 count (NDC

AVKARE recalls Metformin Hydrochloride Extended-Release Tablets 500mg with N-Nitrosodimethylamine (NDMA) impurity above acceptable levels. FDA analysis detected this impurity in specific batch numbers and expiration dates.

Plain-English summary generated from official FDA data by GovInfoNow · How we make summaries

🇺🇸 FDA recall #D-1305-2020Drug AVKARE ›

Lower-risk recall

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

Take action

Contact the company & request your remedy

Recalling firmAVKARE Inc.615 N 1st St · Pulaski, TN 38478-2403

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

AVKARE is recalling Metformin Hydrochloride Extended-Release Tablets 500mg due to N-Nitrosodimethylamine (NDMA) impurities found in some batches. This impurity exceeds the acceptable intake level as detected by the FDA, which could pose a health risk with long-term use. Read more at govinfonow.com/recall/37067-avkare-metformin-hydrochloride-extended-release-tablets-500mg-recall-ndma-impurity.

Source Summary by GovInfoNow · govinfonow.com/recall/37067-avkare-metformin-hydrochloride-extended-release-tablets-500mg-recall-ndma-impurity · Updated October 5, 2026 · FDA enforcement record: FDA #D-1305-2020

Cite this page

“AVKARE Metformin Hydrochloride Extended-Release Tablets 500mg Recall: NDMA Impurity Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37067-avkare-metformin-hydrochloride-extended-release-tablets-500mg-recall-ndma-impurity. Based on FDA recall #D-1305-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1305-2020%22&limit=1).

Why it’s dangerous

The FDA detected N-Nitrosodimethylamine (NDMA) impurities in some batches of Metformin Hydrochloride Extended-Release Tablets 500mg. NDMA is a potential carcinogen, and the impurity levels exceed the acceptable intake level set by the FDA. Long-term use of these tablets could pose a health risk.

Who’s affected

People who have the recalled Metformin Hydrochloride Extended-Release Tablets 500mg (50-count or 90-count bottles) with specific batch numbers and expiration dates listed in the recall notice. Those with diabetes who take this medication are most at risk.

How to tell if you have this one

Check your Metformin Hydrochloride Extended-Release Tablets 500mg bottles for the following: 50-count (NDC 50268-531-15) or 90-count (NDC 42291-610-90) bottles with specific batch numbers and expiration dates listed in the recall notice.

Brand
AVKARE
Category
Drug

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
Nationwide.

Recall number	Product, codes & lots	Quantity
D-1304-2020	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; 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	88,545 bottles
D-1305-2020	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; 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	1,586,913 bottles

Based on the official FDA remedy

What to do — step by step

Check Your Medication
Look for the specific batch numbers and expiration dates listed in the recall notice to determine if your medication is affected.

✎ GovInfoNow

Questions people ask

Is this medication safe to take?

The FDA detected N-Nitrosodimethylamine (NDMA) impurities in some batches of Metformin Hydrochloride Extended-Release Tablets 500mg. These impurities exceed the acceptable intake level, so affected batches should not be used.

How do I know if my medication is recalled?

Check the batch numbers and expiration dates on your medication bottle against the list provided in the recall notice. The affected products include specific counts and NDC numbers listed in the recall.

What should I do if I have the recalled medication?

The recall notice does not specify a remedy for this product. Check the batch numbers and expiration dates to determine if your medication is affected, and contact your healthcare provider for guidance.

Take action

Contact AVKARE

We’ve drafted a message you can send AVKARE to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall D-1305-2020 — AVKARE AVKARE

Hello,

I own a AVKARE that is covered by recall D-1305-2020 from AVKARE.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

Similar recalls

Keep exploring

From people who’ve dealt with this

Experiences, tips, and questions from readers. Every comment is reviewed before it appears.

No comments yet — be the first to share your experience.

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-1305-2020 (June 4, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1305-2020 to see it in context.
Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.