Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Valsartan 80 mg Tablet Recalled by RemedyRepack Inc. Due to CGMP Deviations: Carcinogen impurity detected in API used...

Date: August 10, 2018
Company: RemedyRepack Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact RemedyRepack Inc. directly.

Affected Products

Valsartan 80 mg Tablet,s HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC 61786-0791-19

Quantity: 9 bottles of 90 = 810 tablets

Why Was This Recalled?

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Where Was This Sold?

This product was distributed to 2 states: FL, VA

Affected (2 states)Not affected

About RemedyRepack Inc.

RemedyRepack Inc. has 60 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report