Medications & Supplements/Prescription Drugs

Legacy Pharmaceutical Packaging LLC: Losartan Potassium Tablets Recalled for Impurity Contamination

Agency Publication Date: March 22, 2019

Summary

Legacy Pharmaceutical Packaging LLC is recalling over 5.8 million bottles of Losartan Potassium Tablets (25 mg, 50 mg, and 100 mg) sold under the Camber Pharmaceuticals brand at Wal-Mart. The recall was initiated because testing detected the presence of N-Methylnitrosobutyric acid (NMBA), an impurity that does not meet safety standards for drug manufacturing. These prescription blood pressure medications were distributed to Wal-Mart distribution centers in Arkansas, California, Georgia, Indiana, and Maryland.

Risk

The tablets contain NMBA, which is a known environmental impurity and a potential human carcinogen. Long-term exposure to levels above acceptable limits may increase the risk of cancer.

What You Should Do

Check your prescription bottle for the product name 'Losartan Potassium Tablets, USP' and the manufacturer 'Camber Pharmaceuticals, Inc.'
Verify if your bottle matches one of the following NDC numbers: 68645-577-54 (25 mg), 68645-578-54 (50 mg), or 68645-579-54 (100 mg).
For 25 mg tablets, check for lot numbers 180952 (exp Oct-19), 180953 (exp Dec-19), 181086 (exp Sep-19), or 181572 (exp Jan-20).
For 50 mg tablets, check for lot numbers 180921, 180922, 180923, 180924, 181118, 181119, 181407, 181408, 181573, 181725, 181726, 181948, 181960, 182385, 182386, or 182387 with expiration dates ranging from Sept-19 to Mar-20.
For 100 mg tablets, check for lot numbers 180886, 180887, 180888, 180905, 181123, 181124, 181125, 181351, 181352, 181551, 181628, 181629, 181727, 181728, 181890, 181891, 181897, 182114, 182119, or 182120 with expiration dates ranging from Aug-19 to Jun-20.
Contact your healthcare provider or pharmacist immediately for guidance before you stop taking this medication, as the risk of stopping blood pressure medication abruptly may be higher than the risk of the impurity.
Return any unused product to your pharmacy for a refund and contact Legacy Pharmaceutical Packaging LLC at 1-888-723-3332 for further instructions.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 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, 25 mg (30 tablet bottles)

Model:

NDC 68645-577-54

Recall #: D-1048-2019

Lot Numbers:

180952 (exp Oct-19)

180953 (exp Dec-19)

181086 (exp Sep-19)

181572 (exp Jan-20)

Date Ranges: October 2019, December 2019, September 2019, January 2020

Product: Losartan Potassium Tablets, USP, 50 mg (30 tablet bottles)

Model:

NDC 68645-578-54

Recall #: D-1049-2019

Lot Numbers:

180921 (exp Sep-19)

180922 (exp Oct-19)

180923

180924

181118 (exp Nov-19)

181119 (exp Oct-19)

181407 (exp Nov-19)

181408 (exp Dec-19)

181573

181725

181726 (exp Feb-20)

181948 (exp Mar-20)

181960 (exp Feb-20)

182385

182386

182387 (exp Mar-20)

Date Ranges: September 2019, October 2019, November 2019, December 2019, February 2020, March 2020

Product: Losartan Potassium Tablets, USP, 100 mg (30 tablet bottles)

Model:

NDC 68645-579-54

Recall #: D-1050-2019

Lot Numbers:

180886 (exp Nov-19)

180887

180888

180905 (exp Dec-19)

181123 (exp Sep-19)

181124 (exp Oct-19)

181125 (exp Aug-19)

181351 (exp Nov-19)

181352 (exp Dec-19)

181551 (exp Nov-19)

181628

181629

181727

181728 (exp Jun-20)

181890 (exp Mar-20)

181891

181897 (exp Jun-20)

182114 (exp Mar-20)

182119

182120 (exp Jun-20)

Date Ranges: August 2019, September 2019, October 2019, November 2019, December 2019, March 2020, June 2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82326

Status: Active

Manufacturer: Legacy Pharmaceutical Packaging LLC

Sold By: Wal-Mart

Manufactured In: United States

Units Affected: 3 products (456,732 bottles; 2,851,284 bottles; 2,497,856 bottles)

Distributed To: Arkansas, California, Georgia, Indiana, Maryland

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 the product name 'Losartan Potassium Tablets, USP' and the manufacturer 'Camber Pharmaceuticals, Inc.'

Verify if your bottle matches one of the following NDC numbers: 68645-577-54 (25 mg), 68645-578-54 (50 mg), or 68645-579-54 (100 mg).

For 25 mg tablets, check for lot numbers 180952 (exp Oct-19), 180953 (exp Dec-19), 181086 (exp Sep-19), or 181572 (exp Jan-20).

For 50 mg tablets, check for lot numbers 180921, 180922, 180923, 180924, 181118, 181119, 181407, 181408, 181573, 181725, 181726, 181948, 181960, 182385, 182386, or 182387 with expiration dates ranging from Sept-19 to Mar-20.

For 100 mg tablets, check for lot numbers 180886, 180887, 180888, 180905, 181123, 181124, 181125, 181351, 181352, 181551, 181628, 181629, 181727, 181728, 181890, 181891, 181897, 182114, 182119, or 182120 with expiration dates ranging from Aug-19 to Jun-20.

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

Return any unused product to your pharmacy for a refund and contact Legacy Pharmaceutical Packaging LLC at 1-888-723-3332 for further instructions.

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

Affected Products

Product: Losartan Potassium Tablets, USP, 25 mg (30 tablet bottles)

Model:

NDC 68645-577-54

Recall #: D-1048-2019

Lot Numbers:

180952 (exp Oct-19)

180953 (exp Dec-19)

181086 (exp Sep-19)

181572 (exp Jan-20)

Date Ranges: October 2019, December 2019, September 2019, January 2020

Product: Losartan Potassium Tablets, USP, 50 mg (30 tablet bottles)

Model:

NDC 68645-578-54

Recall #: D-1049-2019

Lot Numbers:

180921 (exp Sep-19)

180922 (exp Oct-19)

180923

180924

181118 (exp Nov-19)

181119 (exp Oct-19)

181407 (exp Nov-19)

181408 (exp Dec-19)

181573

181725

181726 (exp Feb-20)

181948 (exp Mar-20)

181960 (exp Feb-20)

182385

182386

182387 (exp Mar-20)

Date Ranges: September 2019, October 2019, November 2019, December 2019, February 2020, March 2020

Product: Losartan Potassium Tablets, USP, 100 mg (30 tablet bottles)

Model:

NDC 68645-579-54

Recall #: D-1050-2019

Lot Numbers:

180886 (exp Nov-19)

180887

180888

180905 (exp Dec-19)

181123 (exp Sep-19)

181124 (exp Oct-19)

181125 (exp Aug-19)

181351 (exp Nov-19)

181352 (exp Dec-19)

181551 (exp Nov-19)

181628

181629

181727

181728 (exp Jun-20)

181890 (exp Mar-20)

181891

181897 (exp Jun-20)

182114 (exp Mar-20)

182119

182120 (exp Jun-20)

Date Ranges: August 2019, September 2019, October 2019, November 2019, December 2019, March 2020, June 2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82326

Status: Active

Manufacturer: Legacy Pharmaceutical Packaging LLC

Sold By: Wal-Mart

Manufactured In: United States

Units Affected: 3 products (456,732 bottles; 2,851,284 bottles; 2,497,856 bottles)

Distributed To: Arkansas, California, Georgia, Indiana, Maryland