Medications & Supplements/Prescription Drugs

Preferred Pharmaceuticals, Inc: Valsartan Tablets Recalled Due to Carcinogen Impurity

Agency Publication Date: August 17, 2018

Summary

Preferred Pharmaceuticals, Inc. has recalled 9 bottles of Valsartan Tablets USP 320 mg (90-count) because a cancer-causing impurity was detected in the active pharmaceutical ingredient (API) used to make the medication. This prescription drug is used to treat high blood pressure and heart failure. The affected tablets were distributed to a single distributor in Alabama who may have further distributed them to patients. If you are taking this medication, do not stop taking it without first consulting your doctor, as the risk of stopping your blood pressure treatment could be greater than the risk from the impurity.

Risk

The medication contains an impurity classified as a probable human carcinogen, which may increase the risk of cancer with long-term exposure. No specific injuries or adverse events have been reported for this limited batch of nine bottles.

What You Should Do

Check your prescription bottle for Valsartan Tablets USP 320 mg in a 90-count plastic child-resistant bottle with NDC 68788-6882-9.
Locate the lot number on the side of the bottle and verify if it matches lot number G2017F.
If your bottle matches this lot number, contact your healthcare provider or pharmacist immediately to discuss an alternative treatment or replacement medication.
Do NOT stop taking your medication until you have a replacement, as abruptly stopping blood pressure medication can pose immediate health risks.
Return any unused portions of the affected lot G2017F to your pharmacy for a refund and contact Preferred Pharmaceuticals, Inc. at their Anaheim, CA office if you have further questions.
For additional information, 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

Healthcare consultation and 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: Valsartan Tablets USP 320 mg (90-count)

Model:

NDC 68788-6882-9

Recall #: D-1107-2018

Lot Numbers:

G2017F

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80840

Status: Resolved

Manufacturer: Preferred Pharmaceuticals, Inc

Sold By: pharmacies; distributors

Manufactured In: United States

Units Affected: 9 bottles consisting of 90 tables each bottle

Distributed To: Alabama

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 Valsartan Tablets USP 320 mg in a 90-count plastic child-resistant bottle with NDC 68788-6882-9.

Locate the lot number on the side of the bottle and verify if it matches lot number G2017F.

If your bottle matches this lot number, contact your healthcare provider or pharmacist immediately to discuss an alternative treatment or replacement medication.

Do NOT stop taking your medication until you have a replacement, as abruptly stopping blood pressure medication can pose immediate health risks.

Return any unused portions of the affected lot G2017F to your pharmacy for a refund and contact Preferred Pharmaceuticals, Inc. at their Anaheim, CA office if you have further questions.

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