Class II — Potential Health Hazard

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

Valsartan/HCTZ 160 mg/12.5 mg tablet Recalled by RemedyRepack Inc. Due to CGMP Deviations: Carcinogen impurity detected in API used...

Date: July 17, 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/HCTZ 160 mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701

Quantity: 4 HDPE 90-count bottles (360 tablets)

Why Was This Recalled?

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

Where Was This Sold?

Product was distributed to 3 medical facilities in Florida.

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