Medications & Supplements/Prescription Drugs

Direct Rx: Losartan Potassium 100 mg Recalled for Impurity Above Safety Limits

Agency Publication Date: October 5, 2020

Summary

Direct Rx is recalling 33 bottles of Losartan Potassium 100 mg (30-count bottles) because laboratory testing confirmed the presence of an impurity called N-Methylnitrosobutyric acid (NMBA). This chemical was found at levels higher than the acceptable daily intake limit set by manufacturers. Consumers who have these specific bottles should not stop taking their medication without professional guidance, as the risk of stopping blood pressure treatment immediately may outweigh the risk of exposure to the impurity.

Risk

NMBA is a suspected carcinogen; long-term exposure to levels above the acceptable daily intake may increase the risk of cancer. While no immediate injuries or illnesses have been reported for this specific lot, the impurity level exceeds federal safety guidelines for finished drug products.

What You Should Do

Check your medication bottle for Losartan Potassium 100 mg (30-count) with NDC 61919-952-30 and Lot number 27AU1801 with an expiration date of 02/28/2021.
Contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement or alternative prescription before you stop taking the recalled medication.
Return any unused portion of the affected bottles (Lot 27AU1801) to the pharmacy or place of purchase for a refund.
Contact the manufacturer, Direct Rx, at their Dawsonville, Georgia location or through your dispensing pharmacy for further instructions regarding this recall.
Report any adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.
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

Healthcare consultation and pharmacy return

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 100 mg (30 Tabs bottles)

Model:

NDC 61919-952-30

Recall #: D-0018-2021

Lot Numbers:

27AU1801 (Exp. 02/28/2021)

Date Ranges: Expiration date 02/28/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86499

Status: Resolved

Manufacturer: Direct Rx

Sold By: Direct Rx; pharmacies

Manufactured In: United States

Units Affected: 33 bottles

Distributed To: Georgia

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 medication bottle for Losartan Potassium 100 mg (30-count) with NDC 61919-952-30 and Lot number 27AU1801 with an expiration date of 02/28/2021.

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

Return any unused portion of the affected bottles (Lot 27AU1801) to the pharmacy or place of purchase for a refund.

Contact the manufacturer, Direct Rx, at their Dawsonville, Georgia location or through your dispensing pharmacy for further instructions regarding this recall.

Report any adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

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