Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
AvKARE Valsartan and Hydrochlorothiazide 80 mg/12.5 mg tablets Recalled by Avkare Incorporated Due to CGMP Deviations: Carcinogen impurity detected in API used...
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 Incorporated directly.
Affected Products
AvKARE Valsartan and Hydrochlorothiazide 80 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-884-90
Quantity: 12240 bottles
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.
About Avkare Incorporated
Avkare Incorporated has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report