Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Maximum Strength Zantac 150 mg Recalled by Sanofi-Aventis U.S. LLC Due to CGMP Deviations: Presence of NDMA impurity detected in...
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 Sanofi-Aventis U.S. LLC directly.
Affected Products
Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's: 0597-0121-01, 0597-0121-06, 0597-0121-08, 0597-0121-09, 0597-0121-11, 0597-0121-24, 0597-0121-38, 0597-0121-50, 0597-0121-64, 0597-0121-66, 0597-0121-68, 0597-0121-78, 0597-0121-80, 0597-0121-82, 0597-0121-85, 0597-0121-90, 0597-0121-94.
Why Was This Recalled?
CGMP Deviations: Presence of NDMA impurity detected in product.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Sanofi-Aventis U.S. LLC
Sanofi-Aventis U.S. LLC has 22 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report