Medications & Supplements/Prescription Drugs

AVKARE Inc.: Losartan Potassium Tablets Recalled for Potential Impurity Contamination

Agency Publication Date: March 21, 2019

Summary

AvKARE Inc. has voluntarily recalled specific lots of Losartan Potassium (50 mg) and Losartan Potassium/Hydrochlorothiazide (50 mg/12.5 mg and 100 mg/12.5 mg) prescription tablets due to the detection of an impurity called N-Methylnitrosobutyric acid (NMBA). These medications are used to treat high blood pressure and help protect the kidneys from damage due to diabetes. This recall affects unit dose boxes containing 50 tablets distributed nationwide.

Risk

The impurity NMBA is classified as a potential human carcinogen. Exposure to higher-than-acceptable levels of this impurity over a long period could potentially increase the risk of cancer.

What You Should Do

Check your medication packaging for Losartan Potassium 50 mg (NDC 50268-517-15) with lot numbers 20961 (Exp. 09/2019) or 20477 (Exp. 08/2019).
Check your medication packaging for Losartan Potassium and Hydrochlorothiazide 50 mg/12.5 mg (NDC 50268-513-15) with lot number 19454 (Exp. 04/30/2019).
Check your medication packaging for Losartan Potassium and Hydrochlorothiazide 100 mg/12.5 mg (NDC 50268-514-15) with lot number 19326 (Exp. 03/31/2019).
Contact your healthcare provider or pharmacist immediately for guidance before you stop taking the medication, as the risk of stopping blood pressure medication abruptly may be higher than the risk of exposure to the impurity.
Return any unused affected product to your pharmacy for a refund and contact AvKARE Inc. at their Pulaski, TN location for further instructions.
For additional questions or to report a problem, 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

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a 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 (50 Tablets Unit Dose Box)

Model:

NDC 50268-517-15

Recall #: D-1044-2019

Lot Numbers:

20961 (Exp. 09/2019)

20477 (Exp. 08/2019)

Date Ranges: Exp. 09/2019, Exp. 08/2019

Product: Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg (50 Tablets Unit Dose Box)

Model:

NDC 50268-513-15

Recall #: D-1045-2019

Lot Numbers:

19454 (Exp. 04/30/2019)

Date Ranges: Exp. 04/30/2019

Product: Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg (50 Tablets Unit Dose Box)

Model:

NDC 50268-514-15

Recall #: D-1046-2019

Lot Numbers:

19326 (Exp. 03/31/2019)

Date Ranges: Exp. 03/31/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82314

Status: Resolved

Manufacturer: AVKARE Inc.

Sold By: Pharmacies

Manufactured In: United States

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

What You Should Do

Check your medication packaging for Losartan Potassium 50 mg (NDC 50268-517-15) with lot numbers 20961 (Exp. 09/2019) or 20477 (Exp. 08/2019).

Check your medication packaging for Losartan Potassium and Hydrochlorothiazide 50 mg/12.5 mg (NDC 50268-513-15) with lot number 19454 (Exp. 04/30/2019).

Check your medication packaging for Losartan Potassium and Hydrochlorothiazide 100 mg/12.5 mg (NDC 50268-514-15) with lot number 19326 (Exp. 03/31/2019).

Contact your healthcare provider or pharmacist immediately for guidance before you stop taking the medication, as the risk of stopping blood pressure medication abruptly may be higher than the risk of exposure to the impurity.

Return any unused affected product to your pharmacy for a refund and contact AvKARE Inc. at their Pulaski, TN location for further instructions.

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

Affected Products

Product: Losartan Potassium Tablets USP 50 mg (50 Tablets Unit Dose Box)

Model:

NDC 50268-517-15

Recall #: D-1044-2019

Lot Numbers:

20961 (Exp. 09/2019)

20477 (Exp. 08/2019)

Date Ranges: Exp. 09/2019, Exp. 08/2019

Product: Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg (50 Tablets Unit Dose Box)

Model:

NDC 50268-513-15

Recall #: D-1045-2019

Lot Numbers:

19454 (Exp. 04/30/2019)

Date Ranges: Exp. 04/30/2019

Product: Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg (50 Tablets Unit Dose Box)

Model:

NDC 50268-514-15

Recall #: D-1046-2019

Lot Numbers:

19326 (Exp. 03/31/2019)

Date Ranges: Exp. 03/31/2019