Medications & Supplements/Prescription Drugs

American Health Packaging: Valsartan Tablets Recalled Due to Potential Carcinogen Impurity

Agency Publication Date: March 21, 2019

Summary

American Health Packaging is recalling 3,337 cartons of Valsartan Tablets USP 160 mg (generic for Diovan) because the active ingredient was found to contain NDEA (N-Nitrosodimethylamine), a known carcinogen impurity. This prescription medication is used to treat high blood pressure and heart failure, and the recall affects 100-count unit dose blister packs. Consumers should not stop taking their medication without first consulting a healthcare professional, as the risk of stopping treatment may outweigh the risk of exposure to the impurity.

Risk

The tablets contain NDEA, an impurity that is classified as a probable human carcinogen. While the presence of this impurity does not pose an immediate health threat, long-term exposure is associated with an increased risk of cancer.

What You Should Do

Check your medication packaging for Valsartan Tablets USP 160 mg in 100-count (10 x 10) unit dose blisters with the following identifiers: Lot 179791 and an expiration date of March 2020.
Verify the National Drug Codes (NDC) on the packaging; the individual dose NDC is 60687-139-11 and the carton NDC is 60687-139-01.
Contact your healthcare provider or pharmacist immediately to discuss your treatment. Do NOT stop taking your medication until you have a replacement prescription or have been advised to do so by your doctor, as stopping blood pressure medication abruptly can be dangerous.
Return any unused product from the affected lot to your pharmacy to receive a refund and further instructions from the manufacturer.
For additional 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

Contact healthcare provider and return product for refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Valsartan Tablets USP 160 mg, 100 Tablets (10 x 10) per Unit Dose Blisters

Model:

NDC 60687-139-11 (Individual Dose)

NDC 60687-139-01 (Carton)

Lot Numbers:

179791 (Exp Mar 2020)

Date Ranges: Exp March 2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82316

Status: Resolved

Manufacturer: American Health Packaging

Sold By: pharmacies; hospitals

Manufactured In: United States

Units Affected: 3337 cartons

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 Valsartan Tablets USP 160 mg in 100-count (10 x 10) unit dose blisters with the following identifiers: Lot 179791 and an expiration date of March 2020.

Verify the National Drug Codes (NDC) on the packaging; the individual dose NDC is 60687-139-11 and the carton NDC is 60687-139-01.

Contact your healthcare provider or pharmacist immediately to discuss your treatment. Do NOT stop taking your medication until you have a replacement prescription or have been advised to do so by your doctor, as stopping blood pressure medication abruptly can be dangerous.

Return any unused product from the affected lot to your pharmacy to receive a refund and further instructions from the manufacturer.

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