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 tablets 160 mg Recalled by H J Harkins Company Inc dba Pharma Pac Due to Carcinogen impurity detected in API used to manufacture...

Date: July 26, 2018
Company: H J Harkins Company Inc dba Pharma Pac
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 H J Harkins Company Inc dba Pharma Pac directly.

Affected Products

Valsartan tablets 160 mg, 90-count bottle, Rx Only, Repackaged by H.J. Harkins Co, Inc. Grover Beach, CA 93433, NDC 43547-0369-09. Tablet is yellow, capsule-shaped, biconvex, film-coated tablets debossed with 343 on one side and HH on the other side.

Quantity: 540 tablets

Why Was This Recalled?

Carcinogen impurity detected in API used to manufacture drug product.

Where Was This Sold?

Product was distributed to a physician's office.

About H J Harkins Company Inc dba Pharma Pac

H J Harkins Company Inc dba Pharma Pac has 9 total recalls tracked by RecallDetector.

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