The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0541-2020·Announced 2019-12-11

Sanofi Recalls Zantac 150 mg Tablets Due to NDMA Impurity

Sanofi-Aventis U.S. LLC is recalling Regular Strength Zantac 150 mg tablets nationwide because an NDMA impurity was detected. This action addresses current good manufacturing practice (CGMP) deviations.

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, which corresponds to a Severe rating under the rubric. The presence of NDMA impurity represents a significant health risk, justifying a score of 4.

Plain-English summary

Sanofi-Aventis U.S. LLC is recalling Regular Strength Zantac 150 mg tablets (NDC 67751-151-01). The product is distributed by Chattem, Inc., a Sanofi Company, and is available nationwide. The recall covers all lots of the affected product.

The recall was initiated due to current good manufacturing practice (CGMP) deviations. Specifically, the presence of the NDMA impurity was detected in the product. NDMA is a chemical substance that has been associated with potential health risks.

Consumers who have purchased this product should stop using it and contact their healthcare provider or pharmacist for guidance. The source text does not specify a particular return address or refund process, but the recall is active for all lots of the identified NDC.

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 67751-151-01.
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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