Medications & Supplements/Prescription Drugs

Heritage Pharmaceuticals, Inc.: Losartan Potassium Tablets Recalled Due to Impurity Presence

Agency Publication Date: May 22, 2019

Summary

Heritage Pharmaceuticals, Inc. has recalled approximately 81,873 bottles of Losartan Potassium tablets, a prescription medication used to treat high blood pressure. Testing by the FDA found that the medication contains N-Methylnitrosobutyric acid (NMBA), an impurity, at levels higher than the daily safety limit set by the agency. Consumers taking these medications should continue their treatment until they speak with a doctor or pharmacist, as the risk of stopping blood pressure medication suddenly can be dangerous.

Risk

The impurity NMBA is a known nitrosamine that may increase the risk of cancer over long-term exposure when consumed above acceptable daily limits. No specific incidents or injuries have been reported to date for this specific recall.

What You Should Do

Check your prescription bottle label for the product name 'Losartan Potassium Tablets' and the dosage (25 mg, 50 mg, or 100 mg).
Verify your lot number and expiration date against the affected list: for 50 mg (1000ct), check for lots CLO17007A, CLO17008A, CLO17009A (Exp 11/2019); for 100 mg (90ct), check for lots CLO17012A, CLO17013A (Exp 11/2019), CLO18002A (Exp 01/2020), and CLO18020A, CLO18021A, CLO18022A (Exp 04/2020).
For 50 mg (90ct), check for lots CLO17009B, CLO17010A (Exp 11/2019), and CLO18023A (Exp 04/2020).
For 100 mg (1000ct), check for lots CLO17014A (Exp 12/2019), and CLO17015A, CLO17016A, CLO17017A, CLO18001A, CLO18002B (Exp 01/2020). For 25 mg (90ct), check for lot CLO17006A (Exp 11/2019).
Do NOT stop taking your medication immediately; contact your healthcare provider or pharmacist for guidance on a replacement or alternative treatment to avoid health risks from untreated high blood pressure.
Return any unused portions of the affected medication to your pharmacy for a refund and contact Heritage Pharmaceuticals at 1-866-901-DRUG (3784) for further instructions.
If you have additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

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 Tablets, USP 50 mg (1000 film coated tablets)

Model:

NDC 23155-645-10

Lot Numbers:

CLO17007A (Exp 11/2019)

CLO17008A (Exp 11/2019)

CLO17009A (Exp 11/2019)

Date Ranges: 11/2019

Product: Losartan Potassium Tablets USP 100 mg (90 film coated tablets)

Model:

NDC 23155-646-09

Lot Numbers:

CLO17012A (Exp 11/2019)

CLO17013A (Exp 11/2019)

CLO18002A (Exp 01/2020)

CLO18020A (Exp 04/2020)

CLO18021A (Exp 04/2020)

CLO18022A (Exp 04/2020)

Date Ranges: 11/2019, 01/2020, 04/2020

Product: Losartan Potassium Tablets USP 50 mg (90 film coated tablets)

Model:

NDC 23155-645-09

Lot Numbers:

CLO17009B (Exp 11/2019)

CLO17010A (Exp 11/2019)

CLO18023A (Exp 04/2020)

Date Ranges: 11/2019, 04/2020

Product: Losartan Potassium Tablets USP 100 mg (1000 film coated tablets)

Model:

NDC 23155-646-10

Lot Numbers:

CLO17014A (Exp 12/2019)

CLO17015A (Exp 01/2020)

CLO17016A (Exp 01/2020)

CLO17017A (Exp 01/2020)

CLO18001A (Exp 01/2020)

CLO18002B (Exp 01/2020)

Date Ranges: 12/2019, 01/2020

Product: Losartan Potassium Tablets USP 25 mg (90 film coated tablets)

Model:

NDC 23155-644-09

Lot Numbers:

CLO17006A (Exp 11/2019)

Date Ranges: 11/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82782

Status: Resolved

Manufacturer: Heritage Pharmaceuticals, Inc.

Sold By: Pharmacies

Manufactured In: India, United States

Units Affected: 5 products (3012 bottles; 25220 bottles; 34403 bottles; 3697 bottles; 15541 bottles)

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 prescription bottle label for the product name 'Losartan Potassium Tablets' and the dosage (25 mg, 50 mg, or 100 mg).

Verify your lot number and expiration date against the affected list: for 50 mg (1000ct), check for lots CLO17007A, CLO17008A, CLO17009A (Exp 11/2019); for 100 mg (90ct), check for lots CLO17012A, CLO17013A (Exp 11/2019), CLO18002A (Exp 01/2020), and CLO18020A, CLO18021A, CLO18022A (Exp 04/2020).

For 50 mg (90ct), check for lots CLO17009B, CLO17010A (Exp 11/2019), and CLO18023A (Exp 04/2020).

For 100 mg (1000ct), check for lots CLO17014A (Exp 12/2019), and CLO17015A, CLO17016A, CLO17017A, CLO18001A, CLO18002B (Exp 01/2020). For 25 mg (90ct), check for lot CLO17006A (Exp 11/2019).

Do NOT stop taking your medication immediately; contact your healthcare provider or pharmacist for guidance on a replacement or alternative treatment to avoid health risks from untreated high blood pressure.

Return any unused portions of the affected medication to your pharmacy for a refund and contact Heritage Pharmaceuticals at 1-866-901-DRUG (3784) for further instructions.

If you have additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Affected Products

Product: Losartan Potassium Tablets, USP 50 mg (1000 film coated tablets)

Model:

NDC 23155-645-10

Lot Numbers:

CLO17007A (Exp 11/2019)

CLO17008A (Exp 11/2019)

CLO17009A (Exp 11/2019)

Date Ranges: 11/2019

Product: Losartan Potassium Tablets USP 100 mg (90 film coated tablets)

Model:

NDC 23155-646-09

Lot Numbers:

CLO17012A (Exp 11/2019)

CLO17013A (Exp 11/2019)

CLO18002A (Exp 01/2020)

CLO18020A (Exp 04/2020)

CLO18021A (Exp 04/2020)

CLO18022A (Exp 04/2020)

Date Ranges: 11/2019, 01/2020, 04/2020

Product: Losartan Potassium Tablets USP 50 mg (90 film coated tablets)

Model:

NDC 23155-645-09

Lot Numbers:

CLO17009B (Exp 11/2019)

CLO17010A (Exp 11/2019)

CLO18023A (Exp 04/2020)

Date Ranges: 11/2019, 04/2020

Product: Losartan Potassium Tablets USP 100 mg (1000 film coated tablets)

Model:

NDC 23155-646-10

Lot Numbers:

CLO17014A (Exp 12/2019)

CLO17015A (Exp 01/2020)

CLO17016A (Exp 01/2020)

CLO17017A (Exp 01/2020)

CLO18001A (Exp 01/2020)

CLO18002B (Exp 01/2020)

Date Ranges: 12/2019, 01/2020

Product: Losartan Potassium Tablets USP 25 mg (90 film coated tablets)

Model:

NDC 23155-644-09

Lot Numbers:

CLO17006A (Exp 11/2019)

Date Ranges: 11/2019