Sanofi Recalls Regular Strength Zantac 150 mg Due to NDMA Impurity
Sanofi-Aventis U.S. LLC is recalling Regular Strength Zantac 150 mg because the FDA detected the NDMA impurity 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 recall is classified as FDA Class II, and the presence of NDMA, a probable human carcinogen, represents a significant health risk that aligns with the 'Severe' severity criteria for drug recalls involving serious potential harm.
Plain-English summary
Sanofi-Aventis U.S. LLC is recalling Regular Strength Zantac 150 mg (NDC 05269-220-25) 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. NDMA is a chemical that can cause cancer in animals and may increase the risk of cancer in humans.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on alternative treatments. The source text does not specify a return address or refund process.
The recalled product
- Product
- Regular Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 05269-220-25.
- Manufacturer
- Sanofi-Aventis U.S. LLC
- Hazard
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.
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