Sanofi Recalls Zantac 75 mg Tablets Due to NDMA Impurity
Sanofi-Aventis U.S. LLC is recalling Zantac 75 mg tablets nationwide because NDMA impurity was detected. The recall covers all lots of the product.
What this means for you
Illness, injury, or structural failure has been reported. 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 rubric specifies that FDA Class II recalls with significant injury/property-damage reports or hospitalization reports are Severe. While the source text does not explicitly mention hospitalizations, the presence of NDMA impurity in a widely distributed drug is a significant health risk that aligns with the Severe classification criteria for Class II recalls involving potential serious harm.
Plain-English summary
Sanofi-Aventis U.S. LLC is recalling Zantac 75 mg tablets, distributed by Chattem, Inc., a Sanofi Company. The recall is nationwide and includes all lots of the product. The specific NDC codes affected are 0597-0122-01, 0597-0122-08, 0597-0122-13, 0597-0122-37, 0597-0122-40, 0597-0122-54, 0597-0122-61, 0597-0122-81, and 0597-0122-96.
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 impurity that has been associated with potential health risks.
Consumers who have purchased Zantac 75 mg tablets should stop using the product and contact their healthcare provider or pharmacist for guidance on alternative treatments. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 0597-0122-01 0597-0122-08 0597-0122-13 0597-0122-37 0597-0122-40 0597-0122-54 0597-0122-61 0597-0122-81 0597-0122-96
- 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.
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