The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0544-2020·Announced 2019-12-11

Sanofi Recalls Zantac 150 mg Tablets Due to NDMA Impurity

Sanofi-Aventis U.S. LLC is recalling Zantac 150 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 recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the presence of a known carcinogenic impurity (NDMA) in a pharmaceutical product.

Plain-English summary

Sanofi-Aventis U.S. LLC is recalling Zantac 150 mg tablets, distributed by Chattem, Inc., a Sanofi Company. The recall covers all lots of the product, including NDCs 66715-9736-2, 66715-9736-3, and 66715-9736-8. The distribution pattern is nationwide.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of the NDMA impurity in the product. The source text does not specify the quantity of units affected or the exact dates of distribution.

Consumers who have purchased Zantac 150 mg tablets should stop using the product and consult their healthcare provider for guidance on alternative treatments. The source text does not provide specific instructions for returning the product or a dedicated customer service contact number.

The recalled product

Product
Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 66715-9736-2 66715-9736-3 66715-9736-8
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 →

Related recalls

Same manufacturer · Sanofi-Aventis U.S. LLC

See all →

Same hazard · ndma impurity

See all →

Similar recalls