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 Recalled by Northwind Pharmaceuticals LLC Due to CGMP Deviations: Carcinogen impurity detected in API used...

Date: July 18, 2018
Company: Northwind Pharmaceuticals LLC
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 Northwind Pharmaceuticals LLC directly.

Affected Products

Valsartan HCTZ, 160/12.5mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-950-52

Quantity: 43 bottles

Why Was This Recalled?

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

Where Was This Sold?

Indiana

About Northwind Pharmaceuticals LLC

Northwind Pharmaceuticals LLC has 13 total recalls tracked by RecallDetector.

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