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 Tablets Recalled by AVKARE Inc. Due to CGMP Deviations: Carcinogen impurity detected in API used...

Date: August 14, 2018
Company: AVKARE 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 AVKARE Inc. directly.

Affected Products

Valsartan Tablets, USP 160 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-785-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478

Quantity: 818 cartons (40,900 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 nationwide across all 50 states.

Affected (51 states)Not affected

About AVKARE Inc.

AVKARE Inc. has 33 total recalls tracked by RecallDetector.

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