Medications & Supplements/Prescription Drugs

Legacy Pharmaceutical Packaging LLC: Losartan Potassium Tablets Recalled Due to NMBA Impurity

Agency Publication Date: April 2, 2019

Summary

Legacy Pharmaceutical Packaging LLC is recalling 179,544 bottles of Losartan Potassium (50 mg) tablets because testing detected an impurity called N-Methylnitrosobutyric acid (NMBA). This prescription blood pressure medication was packaged in 30-count bottles and distributed to Kroger pharmacies in Arizona, Indiana, and Tennessee. Consumers should continue taking their medication but contact their doctor or pharmacist immediately to discuss an alternative treatment, as the risk of stopping blood pressure medication suddenly may be higher than the risk of the impurity.

Risk

The tablets contain NMBA, which is a known environmental contaminant and a potential human carcinogen. Exposure to this impurity over a long period may increase the risk of cancer.

What You Should Do

Check your prescription bottle for 'Losartan Potassium Tablets, USP, 50 mg' packaged in 30-count bottles with NDC 68645-494-54.
Verify the lot number and expiration date on the side of the bottle: look for Lot 180190 (Exp 10/2020), Lot 180191 (Exp 10/2020), or Lot 181597 (Exp 02/2021).
Do NOT stop taking your medication before talking to your healthcare provider or pharmacist; stopping blood pressure medication abruptly can pose immediate health risks.
Contact your pharmacist to see if a replacement from a different lot or manufacturer is available.
Return any unused product from the affected lots to your pharmacy for a refund and further instructions.
Contact Legacy Pharmaceutical Packaging LLC for more information regarding this recall.
For further questions, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare consultation and pharmacy 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 (30-count bottle)

Model:

NDC 68645-494-54

Recall #: D-1075-2019

Lot Numbers:

180190 (Exp 10/2020)

180191 (Exp 10/2020)

181597 (Exp 02/2021)

Date Ranges: Expiration 10/2020, Expiration 02/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82490

Status: Resolved

Manufacturer: Legacy Pharmaceutical Packaging LLC

Sold By: The Kroger Co

Manufactured In: United States

Units Affected: 179,544 30-count bottles

Distributed To: Arizona, Indiana, Tennessee

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, 50 mg' packaged in 30-count bottles with NDC 68645-494-54.

Verify the lot number and expiration date on the side of the bottle: look for Lot 180190 (Exp 10/2020), Lot 180191 (Exp 10/2020), or Lot 181597 (Exp 02/2021).

Do NOT stop taking your medication before talking to your healthcare provider or pharmacist; stopping blood pressure medication abruptly can pose immediate health risks.

Contact your pharmacist to see if a replacement from a different lot or manufacturer is available.

Return any unused product from the affected lots to your pharmacy for a refund and further instructions.

Contact Legacy Pharmaceutical Packaging LLC for more information regarding this recall.

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