Medications & Supplements/Prescription Drugs

Teva Pharmaceuticals USA: Losartan Potassium Tablets Recalled Due to NMBA Impurity

Agency Publication Date: July 9, 2019

Summary

Teva Pharmaceuticals USA is recalling approximately 5,867,000 tablets of Losartan Potassium (50 mg and 100 mg), a medication used to treat high blood pressure. The recall was initiated because an impurity called N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) was detected in the active pharmaceutical ingredient. NMBA is classified as a potential human carcinogen, meaning long-term exposure could increase the risk of cancer. Affected products were distributed nationwide to major distributors in 90-count and 1000-count bottles.

Risk

The medication contains an impurity called NMBA, which is a known environmental contaminant and a potential human carcinogen. While no immediate injuries have been reported, the presence of this impurity exceeds the acceptable safety limits set by the FDA.

What You Should Do

Identify if you have the 50 mg tablets (NDC 00591-3746-00) by checking the bottle for bulk lot numbers 1169752A or 1169753A, or finished product lot numbers GS017387, GS017651, or GS017479, all with an expiration date of 01/2020.
Identify if you have the 100 mg tablets (NDC 00591-3747-00) by checking for bulk lot numbers 1163892A, 1163893A, 1163894A, or 1163895A, or finished product lot numbers GS017042, GS017043, GS017044, or GS017541, all with an expiration date of 01/2020.
Do not stop taking your medication without consulting your doctor first, as the risks of suddenly stopping blood pressure treatment may be greater than the risk of the impurity.
Contact your healthcare provider or pharmacist to discuss an alternative treatment or to receive a replacement prescription.
Return any unused tablets from the affected lots to your pharmacy for a refund and contact Teva Pharmaceuticals USA for further instructions.
Contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

Full Refund

Pharmacy refund and healthcare consultation

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

Affected Products

Product: LOSARTAN POTASSIUM 50 mg TABLET BULK (90 count and 1000 count bottles)

Model:

NDC 00591-3746-00

Recall #: D-1455-2019

Lot Numbers:

1169752A (Exp 01/2020)

1169753A (Exp 01/2020)

GS017387 (Exp 01/2020)

GS017651 (Exp 01/2020)

GS017479 (Exp 01/2020)

Date Ranges: Expiration Date 01/2020

Product: LOSARTAN POTASSIUM 100 mg TABLET BULK (90 count bottles)

Model:

NDC 00591-3747-00

Recall #: D-1456-2019

Lot Numbers:

1163892A (Exp 01/2020)

1163893A (Exp 01/2020)

1163894A (Exp 01/2020)

1163895A (Exp 01/2020)

GS017042 (Exp 01/2020)

GS017043 (Exp 01/2020)

GS017044 (Exp 01/2020)

GS017541 (Exp 01/2020)

Date Ranges: Expiration Date 01/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83050

Status: Active

Manufacturer: Teva Pharmaceuticals USA

Sold By: 4 major distributors; Golden State Medical

Manufactured In: United States, Malta

Units Affected: 2 products (2,924,000 tablets; 2,943,000 tablets)

Distributed To: Nationwide

Agency Last Updated: October 7, 2019

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 if you have the 50 mg tablets (NDC 00591-3746-00) by checking the bottle for bulk lot numbers 1169752A or 1169753A, or finished product lot numbers GS017387, GS017651, or GS017479, all with an expiration date of 01/2020.

Identify if you have the 100 mg tablets (NDC 00591-3747-00) by checking for bulk lot numbers 1163892A, 1163893A, 1163894A, or 1163895A, or finished product lot numbers GS017042, GS017043, GS017044, or GS017541, all with an expiration date of 01/2020.

Do not stop taking your medication without consulting your doctor first, as the risks of suddenly stopping blood pressure treatment may be greater than the risk of the impurity.

Contact your healthcare provider or pharmacist to discuss an alternative treatment or to receive a replacement prescription.

Return any unused tablets from the affected lots to your pharmacy for a refund and contact Teva Pharmaceuticals USA for further instructions.

Contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Affected Products

Product: LOSARTAN POTASSIUM 50 mg TABLET BULK (90 count and 1000 count bottles)

Model:

NDC 00591-3746-00

Recall #: D-1455-2019

Lot Numbers:

1169752A (Exp 01/2020)

1169753A (Exp 01/2020)

GS017387 (Exp 01/2020)

GS017651 (Exp 01/2020)

GS017479 (Exp 01/2020)

Date Ranges: Expiration Date 01/2020

Product: LOSARTAN POTASSIUM 100 mg TABLET BULK (90 count bottles)

Model:

NDC 00591-3747-00

Recall #: D-1456-2019

Lot Numbers:

1163892A (Exp 01/2020)

1163893A (Exp 01/2020)

1163894A (Exp 01/2020)

1163895A (Exp 01/2020)

GS017042 (Exp 01/2020)

GS017043 (Exp 01/2020)

GS017044 (Exp 01/2020)

GS017541 (Exp 01/2020)

Date Ranges: Expiration Date 01/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83050

Status: Active

Manufacturer: Teva Pharmaceuticals USA

Sold By: 4 major distributors; Golden State Medical

Manufactured In: United States, Malta

Units Affected: 2 products (2,924,000 tablets; 2,943,000 tablets)

Distributed To: Nationwide

Agency Last Updated: October 7, 2019