The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0539-2020·Announced 2019-12-11

Sanofi Recalls Maximum Strength Zantac 150 mg Due to NDMA Impurity

Sanofi-Aventis U.S. LLC is recalling Maximum Strength Zantac 150 mg tablets nationwide 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 impurity in a drug product constitutes a significant health hazard, aligning with the 'Severe' criteria for significant injury/property-damage reports or high-risk contamination.

Plain-English summary

Sanofi-Aventis U.S. LLC is recalling Maximum Strength Zantac 150 mg tablets, distributed by Chattem, Inc. The recall covers all lots of the product and is being conducted 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 be found in some medications and is associated with potential health risks.

Consumers who have purchased Maximum Strength Zantac 150 mg should stop using the product and contact their healthcare provider or pharmacist for guidance on alternative treatments or disposal instructions.

The recalled product

Product
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…
Manufacturer
Sanofi-Aventis U.S. LLC
Category
Drug — Prescription/OTC Medication
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.

See all 12 products in this recall →

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