Medications & Supplements/Prescription Drugs

Sandoz, Inc: Losartan Potassium and Hydrochlorothiazide Tablets Recalled for Impurity

Agency Publication Date: November 27, 2018

Summary

Sandoz, Inc. is recalling 170 bottles of Losartan Potassium and Hydrochlorothiazide Tablets, USP (100 mg/25 mg) due to the presence of an impurity called N-nitrosodiethylamine (NDEA). This impurity was found in the active ingredient used to manufacture the medication at levels higher than the interim acceptable daily limit set by the FDA. The recall affects 1000-count bottles that were distributed in Ohio and Puerto Rico.

Risk

NDEA is classified as a probable human carcinogen, meaning it may increase the risk of cancer with long-term exposure. While no immediate injuries have been reported, the levels of this impurity in the tablets exceed safety thresholds established for daily intake.

What You Should Do

Check your medication bottle for the product name 'Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg' and the NDC number 0781-5207-10.
Verify if your bottle is from Lot Number JB8912 with an expiration date of 06/2020.
Contact your healthcare provider or pharmacist immediately for guidance before you stop taking this medication, as the risk of stopping a blood pressure medication without an alternative may be greater than the risk of continued exposure to the impurity.
Return any unused portion of the affected medication to your pharmacy for a refund and to ensure it is properly disposed of.
For further instructions regarding the recall process, contact Sandoz, Inc. at their Princeton, NJ headquarters or visit the FDA website at www.fda.gov/safety/recalls.
For additional questions, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

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: Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg (1000-count bottle)

Model:

NDC 0781-5207-10

Lot Numbers:

JB8912 (Exp. 06/2020)

Date Ranges: Exp. 06/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81485

Status: Active

Manufacturer: Sandoz, Inc

Sold By: pharmacies; healthcare providers

Manufactured In: Slovenia, United States

Units Affected: 170 HDPE bottles

Distributed To: Ohio, Puerto Rico

Agency Last Updated: January 14, 2019

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 the product name 'Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg' and the NDC number 0781-5207-10.

Verify if your bottle is from Lot Number JB8912 with an expiration date of 06/2020.

Contact your healthcare provider or pharmacist immediately for guidance before you stop taking this medication, as the risk of stopping a blood pressure medication without an alternative may be greater than the risk of continued exposure to the impurity.

Return any unused portion of the affected medication to your pharmacy for a refund and to ensure it is properly disposed of.

For further instructions regarding the recall process, contact Sandoz, Inc. at their Princeton, NJ headquarters or visit the FDA website at www.fda.gov/safety/recalls.

For additional questions, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).