Medications & Supplements/Prescription Drugs

Macleods Pharma Usa Inc: Losartan Potassium and Hydrochlorothiazide Recalled for Carcinogen Impurity

Agency Publication Date: March 21, 2019

Summary

Approximately 9,695 bottles of Macleods Losartan Potassium and Hydrochlorothiazide Tablets (100 mg/25 mg) are being recalled because a carcinogen impurity called NDEA (N-Nitrosodimethylamine) was detected in the active ingredient. These prescription tablets are used to treat high blood pressure. Consumers should not stop taking their medication without first consulting their healthcare provider or pharmacist, as the risk of stopping high blood pressure treatment could be greater than the risk of exposure to the impurity.

Risk

The tablets contain NDEA, which is a chemical classified as a probable human carcinogen. Long-term exposure to this impurity at levels above acceptable limits is associated with an increased risk of developing cancer.

What You Should Do

Identify your medication by checking the label for 'Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg' in 90-count bottles with NDC number 33342-0052-10.
Check the bottle for Lot number BLM715A and an expiration date of Jul-19 to confirm your product is affected.
Contact your healthcare provider or pharmacist immediately to discuss an alternative treatment or to obtain a replacement before you stop taking the recalled medication.
Return any unused tablets from the affected lot to the pharmacy where you purchased them for a refund.
Contact Macleods Pharma USA, Inc. at their headquarters in Plainsboro, NJ, for further instructions regarding this recall.
For additional questions or to report a side effect, 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

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 and Hydrochlorothiazide Tablets, USP 100 mg/25 mg (90 count bottles)

Model:

NDC 33342-0052-10

Lot Numbers:

BLM715A

Date Ranges: Jul-19

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82147

Status: Resolved

Manufacturer: Macleods Pharma Usa Inc

Sold By: Pharmacies

Manufactured In: India, United States

Units Affected: 9695 bottles

Distributed To: New Jersey, New York, Florida

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 label for 'Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg' in 90-count bottles with NDC number 33342-0052-10.

Check the bottle for Lot number BLM715A and an expiration date of Jul-19 to confirm your product is affected.

Contact your healthcare provider or pharmacist immediately to discuss an alternative treatment or to obtain a replacement before you stop taking the recalled medication.

Return any unused tablets from the affected lot to the pharmacy where you purchased them for a refund.

Contact Macleods Pharma USA, Inc. at their headquarters in Plainsboro, NJ, for further instructions regarding this recall.

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