Sanofi Recalls Zantac 75 mg Due to NDMA Impurity
Sanofi is recalling Regular Strength Zantac 75 mg tablets nationwide because an NDMA impurity was detected in the product.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. According to the rubric, an FDA Class II recall with significant injury or property damage reports, or structural defects, is rated as Severe (4).
Plain-English summary
Sanofi-Aventis U.S. LLC is recalling Regular Strength Zantac 75 mg tablets, distributed by Chattem, Inc. The recall covers all lots of the product and is distributed nationwide.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of the NDMA impurity in the product.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on next steps.
The recalled product
- Product
- Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 68151-2584-0.
- Manufacturer
- Sanofi-Aventis U.S. LLC
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- all lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Sanofi-Aventis U.S. LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 12 products in this recall →Related recalls
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