US Drug Recall Register
Class II · Moderate risk Ongoing Initiated Oct 22, 2019 (7 years ago)

Regular Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

CGMP Deviations: Presence of NDMA impurity detected in product.

What was recalled

Regular Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 67751-151-01.

Recalling firm
Sanofi-Aventis U.S. LLC
NDC code
67751-151-01
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0541-2020

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.