Medications & Supplements/Prescription Drugs

MAJOR PHARMACEUTICALS: Valsartan Tablets Recalled Due to Potential Carcinogen Impurity

Agency Publication Date: July 20, 2018

Summary

Major Pharmaceuticals is recalling 10,020 cartons of Valsartan Tablets, USP (80 mg and 160 mg), a prescription medication used to treat high blood pressure and heart failure. The recall was initiated because a cancer-causing impurity was detected in the active pharmaceutical ingredient (API) used to manufacture these specific drugs. This recall affects unit dose cartons distributed nationwide between 2017 and 2018.

Risk

The tablets contain a carcinogen impurity that may increase the risk of cancer over long-term exposure. While no immediate injuries have been reported, the presence of this impurity violates safety standards for drug manufacturing.

What You Should Do

Identify if you have the affected 80 mg Valsartan Tablets by checking for NDC# 0904-6594-61 and lot numbers T-01270, T-01466, T-01500, T-01596, T-01625, T-01712, T-01795, or T-01807.
Identify if you have the affected 160 mg Valsartan Tablets by checking for NDC# 0904-6594-61 or 0904-6595-61 and lot numbers T-01269, T-01524, T-01646, T-01668, or T-01788.
Contact your healthcare provider or pharmacist immediately for guidance before you stop taking your medication, as suddenly stopping blood pressure medication can pose health risks.
Return any unused portions of the affected lots to your pharmacy to receive a refund and to ensure the product is properly disposed of.
Contact Major Pharmaceuticals at their Livonia, Michigan headquarters or through your local distributor for additional information regarding the return process.
For further questions about this recall, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

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: Unit Dose Valsartan Tablets, USP, 80 mg

Model:

NDC# 0904-6594-61

Item # 302086

Recall #: D-0966-2018

Lot Numbers:

T-01270 (Exp: 7/18)

T-01466 (Exp: 7/18)

T-01500 (Exp: 2/19)

T-01596 (Exp: 2/19)

T-01625 (Exp: 2/19)

T-01712 (Exp: 2/19)

T-01795 (Exp: 5/19)

T-01807 (Exp: 5/19)

Date Ranges: Expiry: 7/18, Expiry: 2/19, Expiry: 5/19

Product: Unit Dose Valsartan Tablets, USP, 160 mg

Model:

NDC# 0904-6594-61

NDC# 0904-6595-61

Item # 302087

Recall #: D-0967-2018

Lot Numbers:

T-01269 (Exp: 7/18)

T-01524 (Exp: 2/19)

T-01646 (Exp: 5/19)

T-01668 (Exp: 5/19)

T-01788 (Exp: 5/19)

Date Ranges: Expiry: 7/18, Expiry: 2/19, Expiry: 5/19

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80557

Status: Resolved

Manufacturer: MAJOR PHARMACEUTICALS

Sold By: Major Pharmaceuticals; The Harvard Drug Group

Manufactured In: United States

Units Affected: 2 products (5,464 cartons; 4,556 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

Identify if you have the affected 80 mg Valsartan Tablets by checking for NDC# 0904-6594-61 and lot numbers T-01270, T-01466, T-01500, T-01596, T-01625, T-01712, T-01795, or T-01807.

Identify if you have the affected 160 mg Valsartan Tablets by checking for NDC# 0904-6594-61 or 0904-6595-61 and lot numbers T-01269, T-01524, T-01646, T-01668, or T-01788.

Contact your healthcare provider or pharmacist immediately for guidance before you stop taking your medication, as suddenly stopping blood pressure medication can pose health risks.

Return any unused portions of the affected lots to your pharmacy to receive a refund and to ensure the product is properly disposed of.

Contact Major Pharmaceuticals at their Livonia, Michigan headquarters or through your local distributor for additional information regarding the return process.

For further questions about this recall, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Affected Products

Product: Unit Dose Valsartan Tablets, USP, 80 mg

Model:

NDC# 0904-6594-61

Item # 302086

Recall #: D-0966-2018

Lot Numbers:

T-01270 (Exp: 7/18)

T-01466 (Exp: 7/18)

T-01500 (Exp: 2/19)

T-01596 (Exp: 2/19)

T-01625 (Exp: 2/19)

T-01712 (Exp: 2/19)

T-01795 (Exp: 5/19)

T-01807 (Exp: 5/19)

Date Ranges: Expiry: 7/18, Expiry: 2/19, Expiry: 5/19

Product: Unit Dose Valsartan Tablets, USP, 160 mg

Model:

NDC# 0904-6594-61

NDC# 0904-6595-61

Item # 302087

Recall #: D-0967-2018

Lot Numbers:

T-01269 (Exp: 7/18)

T-01524 (Exp: 2/19)

T-01646 (Exp: 5/19)

T-01668 (Exp: 5/19)

T-01788 (Exp: 5/19)

Date Ranges: Expiry: 7/18, Expiry: 2/19, Expiry: 5/19