Medications & Supplements/Prescription Drugs

Nostrum Laboratories Inc: Metformin Extended-Release Tablets Recalled for Excessive NDMA Impurity

Agency Publication Date: November 5, 2020

Summary

Nostrum Laboratories Inc. is recalling 33,839 bottles of Metformin Hydrochloride Extended-Release Tablets (USP 500 mg and 750 mg) after testing revealed levels of N-Nitrosodimethylamine (NDMA) that exceed acceptable daily limits. NDMA is a substance that is classified as a probable human carcinogen. Consumers using these specific prescriptions for diabetes management should not stop taking their medication without first consulting their doctor, as the risks of uncontrolled blood sugar may outweigh the risks of the impurity.

Risk

The tablets contain NDMA, an environmental contaminant and a probable human carcinogen, at levels above what is considered safe for long-term daily intake. While no immediate injuries have been reported, long-term exposure to elevated levels of NDMA is associated with an increased risk of cancer.

What You Should Do

Identify your medication by checking the NDC numbers and lot information on the bottle label. This recall affects Metformin 750 mg (NDC 29033-056-01, lots MET200101, MET200301) and Metformin 500 mg (NDC 29033-055-01, lots MET100201, MET100401) with an expiration date of 05/2022.
Do NOT stop taking your medication before talking to your healthcare provider or pharmacist. Stopping a diabetes medication suddenly can pose a serious immediate health risk.
Contact your doctor or pharmacist to discuss a replacement prescription or an alternative treatment option if your medication is part of the recalled lots.
Return any unused portions of the recalled medication to the pharmacy where you purchased it for a refund and further instructions.
Contact Nostrum Laboratories Inc. directly at 1800 N Topping Ave, Kansas City, MO 64120, for additional questions regarding this recall.
For further information or to report adverse health events, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Contact healthcare provider and return to pharmacy

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 (100 count bottles)

Model:

NDC 29033-056-01

Recall #: D-0067-2021

Lot Numbers:

MET200101 (Exp 05/2022)

MET200301 (Exp 05/2022)

Date Ranges: EXP 05/2022

Product: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg (100 count bottles)

Model:

NDC 29033-055-01

Recall #: D-0068-2021

Lot Numbers:

MET100201 (Exp 05/2022)

MET100401 (Exp 05/2022)

Date Ranges: EXP 05/2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86653

Status: Active

Manufacturer: Nostrum Laboratories Inc

Sold By: Pharmacies nationwide

Manufactured In: United States

Units Affected: 2 products (12,967 bottles; 20,872 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

Identify your medication by checking the NDC numbers and lot information on the bottle label. This recall affects Metformin 750 mg (NDC 29033-056-01, lots MET200101, MET200301) and Metformin 500 mg (NDC 29033-055-01, lots MET100201, MET100401) with an expiration date of 05/2022.

Do NOT stop taking your medication before talking to your healthcare provider or pharmacist. Stopping a diabetes medication suddenly can pose a serious immediate health risk.

Contact your doctor or pharmacist to discuss a replacement prescription or an alternative treatment option if your medication is part of the recalled lots.

Return any unused portions of the recalled medication to the pharmacy where you purchased it for a refund and further instructions.

Contact Nostrum Laboratories Inc. directly at 1800 N Topping Ave, Kansas City, MO 64120, for additional questions regarding this recall.

For further information or to report adverse health events, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Metformin Hydrochloride Extended-Release Tablets, USP 750 mg (100 count bottles)

Model:

NDC 29033-056-01

Recall #: D-0067-2021

Lot Numbers:

MET200101 (Exp 05/2022)

MET200301 (Exp 05/2022)

Date Ranges: EXP 05/2022

Product: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg (100 count bottles)

Model:

NDC 29033-055-01

Recall #: D-0068-2021

Lot Numbers:

MET100201 (Exp 05/2022)

MET100401 (Exp 05/2022)

Date Ranges: EXP 05/2022