Medications & Supplements/Prescription Drugs

AVKARE Inc.: Metformin ER Tablets Recalled for NDMA Impurity Above Acceptable Levels

Agency Publication Date: June 12, 2020

Summary

AVKARE Inc. is recalling approximately 1.67 million bottles of Metformin Hydrochloride Extended-Release (ER) Tablets (500 mg and 750 mg) after FDA testing detected levels of N-Nitrosodimethylamine (NDMA) that exceed acceptable safety limits. These prescription medications, used to control blood sugar in adults with type 2 diabetes, were distributed nationwide in various bottle sizes ranging from 50 to 1,000 count. The recall was initiated due to deviations from Current Good Manufacturing Practice (CGMP) and the presence of this impurity.

Risk

NDMA is classified as a probable human carcinogen, meaning long-term exposure to levels above the recommended limit may increase the risk of developing cancer.

What You Should Do

Check your medication bottle for the following NDC numbers: 42291-611-90 (90 ct), 42291-611-18 (180 ct), 42291-611-50 (500 ct) for the 750 mg strength; and 50268-531-15 (50 ct), 42291-610-90 (90 ct), 42291-610-18 (180 ct), 42291-610-36 (360 ct), 42291-610-10 (1,000 ct) for the 500 mg strength.
Identify your lot number and expiration date on the packaging. Affected 750 mg lots include 23069, 24571, 25310, 26391, 22542, 23345, 24032, 24624, 24631, 25381, 25907, 26478, 22348, 22405, 22406, 22740, 23346, 23926, 24364, 25014, 25334, 25906, and 26392 with expiration dates between June 2020 and January 2022.
Check affected 500 mg lots, which include specific codes such as 23537, 25751, 22073, 26588, 22202, 26589, 22430, 26591, and a series of HH, HK, HB, HC, HD, HE, HF, HG, and HL prefixed codes (e.g., HH01618A through HB06620A) with expiration dates ranging from June 2020 through February 2022.
Do NOT stop taking your medication without first talking to your doctor or pharmacist. Stopping metformin suddenly can pose a greater health risk to patients with type 2 diabetes than the impurity.
Contact your healthcare provider or pharmacist for guidance on obtaining a replacement prescription or an alternative treatment for your condition.
Return any unused, affected product to your pharmacy for a refund and contact AVKARE Inc. for further instructions regarding the return process.
For additional questions or to report adverse events, contact the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare provider consultation and pharmacy refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Metformin Hydrochloride Extended-Release Tablets, USP 750 mg (90 count)

Model:

NDC 42291-611-90

Lot Numbers:

23069 (Exp. 11/30/2020)

24571 (Exp. 05/31/2021)

25310 (Exp. 07/31/2021)

26391 (Exp. 01/31/2022)

Date Ranges: Exp. 11/30/2020, Exp. 05/31/2021, Exp. 07/31/2021, Exp. 01/31/2022

Product: Metformin Hydrochloride Extended-Release Tablets, USP 750 mg (180 count)

Model:

NDC 42291-611-18

Lot Numbers:

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)

Date Ranges: Exp. 06/30/2020, Exp. 11/30/2020, Exp. 03/31/2021, Exp. 07/31/2021, Exp. 05/31/2021, Exp. 08/31/2021, Exp. 10/31/2021, Exp. 01/31/2022

Product: Metformin Hydrochloride Extended-Release Tablets, USP 750 mg (500 count)

Model:

NDC 42291-611-50

Lot Numbers:

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)

Date Ranges: Exp. 06/30/2020, Exp. 11/30/2020, Exp. 03/31/2021, Exp. 05/31/2021, Exp. 07/31/2021, Exp. 09/30/2021, Exp. 10/31/2021, Exp. 01/31/2022

Product: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg (Various counts)

Model:

NDC 50268-531-15

NDC 42291-610-90

NDC 42291-610-18

NDC 42291-610-36

NDC 42291-610-10

Lot Numbers:

23537 (Exp. 06/30/2020)

25751 (Exp. 07/31/2021)

22073 (Exp. 06/30/2020)

26588 (Exp. 02/28/2022)

22202 (Exp. 06/30/2020)

26589 (Exp. 02/28/2022)

22430 (Exp. 06/30/2020)

26591 (Exp. 02/28/2022)

HH01618A (Exp. 07/31/2020)

HK13618A (Exp. 11/30/2020)

HA00520A (Exp. 01/31/2022)

HB06620A (Exp. 02/28/2022)

Date Ranges: Exp. June 2020 - February 2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85811

Status: Resolved

Manufacturer: AVKARE Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 2 products (88,545 bottles; 1,586,913 bottles)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medication bottle for the following NDC numbers: 42291-611-90 (90 ct), 42291-611-18 (180 ct), 42291-611-50 (500 ct) for the 750 mg strength; and 50268-531-15 (50 ct), 42291-610-90 (90 ct), 42291-610-18 (180 ct), 42291-610-36 (360 ct), 42291-610-10 (1,000 ct) for the 500 mg strength.

Identify your lot number and expiration date on the packaging. Affected 750 mg lots include 23069, 24571, 25310, 26391, 22542, 23345, 24032, 24624, 24631, 25381, 25907, 26478, 22348, 22405, 22406, 22740, 23346, 23926, 24364, 25014, 25334, 25906, and 26392 with expiration dates between June 2020 and January 2022.

Check affected 500 mg lots, which include specific codes such as 23537, 25751, 22073, 26588, 22202, 26589, 22430, 26591, and a series of HH, HK, HB, HC, HD, HE, HF, HG, and HL prefixed codes (e.g., HH01618A through HB06620A) with expiration dates ranging from June 2020 through February 2022.

Do NOT stop taking your medication without first talking to your doctor or pharmacist. Stopping metformin suddenly can pose a greater health risk to patients with type 2 diabetes than the impurity.

Contact your healthcare provider or pharmacist for guidance on obtaining a replacement prescription or an alternative treatment for your condition.

Return any unused, affected product to your pharmacy for a refund and contact AVKARE Inc. for further instructions regarding the return process.

For additional questions or to report adverse events, contact the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls.

Affected Products

Product: Metformin Hydrochloride Extended-Release Tablets, USP 750 mg (90 count)

Model:

NDC 42291-611-90

Lot Numbers:

23069 (Exp. 11/30/2020)

24571 (Exp. 05/31/2021)

25310 (Exp. 07/31/2021)

26391 (Exp. 01/31/2022)

Date Ranges: Exp. 11/30/2020, Exp. 05/31/2021, Exp. 07/31/2021, Exp. 01/31/2022

Product: Metformin Hydrochloride Extended-Release Tablets, USP 750 mg (180 count)

Model:

NDC 42291-611-18

Lot Numbers:

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)

Date Ranges: Exp. 06/30/2020, Exp. 11/30/2020, Exp. 03/31/2021, Exp. 07/31/2021, Exp. 05/31/2021, Exp. 08/31/2021, Exp. 10/31/2021, Exp. 01/31/2022

Product: Metformin Hydrochloride Extended-Release Tablets, USP 750 mg (500 count)

Model:

NDC 42291-611-50

Lot Numbers:

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)

Date Ranges: Exp. 06/30/2020, Exp. 11/30/2020, Exp. 03/31/2021, Exp. 05/31/2021, Exp. 07/31/2021, Exp. 09/30/2021, Exp. 10/31/2021, Exp. 01/31/2022

Product: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg (Various counts)

Model:

NDC 50268-531-15

NDC 42291-610-90

NDC 42291-610-18

NDC 42291-610-36

NDC 42291-610-10

Lot Numbers:

23537 (Exp. 06/30/2020)

25751 (Exp. 07/31/2021)

22073 (Exp. 06/30/2020)

26588 (Exp. 02/28/2022)

22202 (Exp. 06/30/2020)

26589 (Exp. 02/28/2022)

22430 (Exp. 06/30/2020)

26591 (Exp. 02/28/2022)

HH01618A (Exp. 07/31/2020)

HK13618A (Exp. 11/30/2020)

HA00520A (Exp. 01/31/2022)

HB06620A (Exp. 02/28/2022)

Date Ranges: Exp. June 2020 - February 2022