Medications & Supplements/Prescription Drugs

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

Agency Publication Date: April 7, 2020

Summary

Teva Pharmaceuticals USA is recalling several lots of Losartan Potassium tablets (25 mg, 50 mg, and 100 mg) 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 ingredient used to make the tablets. These specific products were distributed in bulk to a re-packager and are identified by the NDC codes 0591-3745-00, 0591-3746-00, and 0591-3747-00. Consumers currently taking this medication should not stop use without consulting their doctor, as the risk of stopping the medication suddenly may be higher than the risk of the impurity.

Risk

The tablets contain a chemical impurity (NMBA) that was detected during testing of the active pharmaceutical ingredient. NMBA is classified as a potential human carcinogen, meaning long-term exposure could potentially increase the risk of cancer.

What You Should Do

Check your prescription bottle for Losartan Potassium Tablets, USP (25 mg, 50 mg, or 100 mg) with the following NDC codes: 0591-3745-00, 0591-3746-00, or 0591-3747-00.
Verify if your medication belongs to the affected lots: for 25 mg tablets, check for lots 1207344A (Exp 06/2020), 1207343A (Exp 07/2020), or 1207342A (Exp 07/2020).
For 50 mg tablets, check for lots 1195625A, 1195624A, or 1195623A with an expiration date of 03/2020.
For 100 mg tablets, check for lots 1178533A through 1178546A with an expiration date of 03/2020.
Contact your healthcare provider or pharmacist immediately if you believe you have the recalled medication to discuss an alternative treatment or a replacement prescription.
Return any unused product to your pharmacy for a refund and contact Teva Pharmaceuticals USA at 1-888-838-2872 for further instructions.
For additional questions, 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 product.

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 TABLETS, USP 25 mg, Bulk

Model:

NDC 0591-3745-00

Lot Numbers:

1207344A (Exp 06/2020)

1207343A (Exp 07/2020)

1207342A (Exp 07/2020)

Date Ranges: 06/2020, 07/2020

Product: LOSARTAN POTASSIUM TABLETS, USP 50 mg, Bulk

Model:

NDC 0591-3746-00

Lot Numbers:

1195625A (Exp 03/2020)

1195624A (Exp 03/2020)

1195623A (Exp 03/2020)

Date Ranges: 03/2020

Product: LOSARTAN POTASSIUM TABLETS, USP 100 mg, Bulk

Model:

NDC 0591-3747-00

Lot Numbers:

1178533A (Exp 03/2020)

1178534A (Exp 03/2020)

1178535A (Exp 03/2020)

1178536A (Exp 03/2020)

1178537A (Exp 03/2020)

1178538A (Exp 03/2020)

1178539A (Exp 03/2020)

1178540A (Exp 03/2020)

1178541A (Exp 03/2020)

1178542A (Exp 03/2020)

1178543A (Exp 03/2020)

1178544A (Exp 03/2020)

1178545A (Exp 03/2020)

1178546A (Exp 03/2020)

Date Ranges: 03/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85306

Status: Active

Manufacturer: Teva Pharmaceuticals USA

Sold By: re-packager

Manufactured In: United States, Malta

Distributed To: California

Agency Last Updated: April 14, 2020

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 prescription bottle for Losartan Potassium Tablets, USP (25 mg, 50 mg, or 100 mg) with the following NDC codes: 0591-3745-00, 0591-3746-00, or 0591-3747-00.

Verify if your medication belongs to the affected lots: for 25 mg tablets, check for lots 1207344A (Exp 06/2020), 1207343A (Exp 07/2020), or 1207342A (Exp 07/2020).

For 50 mg tablets, check for lots 1195625A, 1195624A, or 1195623A with an expiration date of 03/2020.

For 100 mg tablets, check for lots 1178533A through 1178546A with an expiration date of 03/2020.

Contact your healthcare provider or pharmacist immediately if you believe you have the recalled medication to discuss an alternative treatment or a replacement prescription.

Return any unused product to your pharmacy for a refund and contact Teva Pharmaceuticals USA at 1-888-838-2872 for further instructions.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: LOSARTAN POTASSIUM TABLETS, USP 25 mg, Bulk

Model:

NDC 0591-3745-00

Lot Numbers:

1207344A (Exp 06/2020)

1207343A (Exp 07/2020)

1207342A (Exp 07/2020)

Date Ranges: 06/2020, 07/2020

Product: LOSARTAN POTASSIUM TABLETS, USP 50 mg, Bulk

Model:

NDC 0591-3746-00

Lot Numbers:

1195625A (Exp 03/2020)

1195624A (Exp 03/2020)

1195623A (Exp 03/2020)

Date Ranges: 03/2020

Product: LOSARTAN POTASSIUM TABLETS, USP 100 mg, Bulk

Model:

NDC 0591-3747-00

Lot Numbers:

1178533A (Exp 03/2020)

1178534A (Exp 03/2020)

1178535A (Exp 03/2020)

1178536A (Exp 03/2020)

1178537A (Exp 03/2020)

1178538A (Exp 03/2020)

1178539A (Exp 03/2020)

1178540A (Exp 03/2020)

1178541A (Exp 03/2020)

1178542A (Exp 03/2020)

1178543A (Exp 03/2020)

1178544A (Exp 03/2020)

1178545A (Exp 03/2020)

1178546A (Exp 03/2020)

Date Ranges: 03/2020