Medications & Supplements/Prescription Drugs

MAJOR PHARMACEUTICALS: Losartan Potassium Tablets Recalled for Excessive Impurity Levels

Agency Publication Date: July 9, 2019

Summary

Major Pharmaceuticals has recalled 3,102 cartons (totaling 310,200 tablets) of Losartan Potassium Tablets (50 mg), a prescription medication used to treat high blood pressure. The recall was initiated because laboratory testing found an impurity called N-Methylnitrosobutyric acid (NMBA) at levels higher than the daily limit set by the FDA. This specific defect occurred during the manufacturing process and affects the finished product. These tablets were distributed nationwide in 100-count unit dose cartons.

Risk

The presence of the impurity NMBA above acceptable levels poses a potential long-term risk to consumers, as it is classified as a possible human carcinogen. While no immediate injuries have been reported, consuming higher-than-permitted levels of this impurity over time could increase the risk of adverse health effects.

What You Should Do

Check your medication packaging for Losartan Potassium Tablets, USP, 50 mg in 100-count unit dose cartons (10 x 10 cards) with NDC# 0904-6390-61.
Verify if your medication belongs to Lot Number R-00474 with an expiration date of 07/2019.
If you have the affected medication, contact your healthcare provider or pharmacist immediately to discuss your treatment options and obtain a replacement prescription before you stop taking the medicine.
Return any unused portions of the recalled medication to the pharmacy where it was purchased to receive a refund.
Contact Major Pharmaceuticals or its parent company, The Harvard Drug Group, for further instructions regarding this recall.
For additional questions or to report adverse effects, 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

Guidance and refund

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 (50 mg, 100 count Unit Dose Cartons)

Model:

NDC# 0904-6390-61

Major Item # 301835

Recall #: D-1466-2019

Lot Numbers:

R-00474 (Exp 07/2019)

Date Ranges: 07/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83208

Status: Resolved

Manufacturer: MAJOR PHARMACEUTICALS

Sold By: pharmacies; hospitals

Manufactured In: United States

Units Affected: 3,102 Cartons (310,200 tablets)

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

Risk

What You Should Do

Check your medication packaging for Losartan Potassium Tablets, USP, 50 mg in 100-count unit dose cartons (10 x 10 cards) with NDC# 0904-6390-61.

Verify if your medication belongs to Lot Number R-00474 with an expiration date of 07/2019.

If you have the affected medication, contact your healthcare provider or pharmacist immediately to discuss your treatment options and obtain a replacement prescription before you stop taking the medicine.

Return any unused portions of the recalled medication to the pharmacy where it was purchased to receive a refund.

Contact Major Pharmaceuticals or its parent company, The Harvard Drug Group, for further instructions regarding this recall.

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