Sanofi Cool Mint Zantac 150mg Recall: NDMA Impurity Risk

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Recalling firmSanofi-Aventis U.S. LLC55 Corporate Dr · Bridgewater, NJ 08807-1265

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Sanofi is recalling Cool Mint Maximum Strength Zantac 150mg tablets because they contain NDMA impurity. This impurity has been found in the product and could pose health risks, though the exact risk level isn't specified in the recall notice.

Why it’s dangerous

NDMA (N-nitrosodimethylamine) is a potential carcinogen that has been detected in the product. While the presence of this impurity in medications is rare, it could pose health risks with long-term use. The recall does not specify the exact health risks associated with this impurity.

Who’s affected

People who have taken or are using Cool Mint Maximum Strength Zantac 150mg tablets from the recalled lots are affected. Those with pre-existing conditions or who take the medication regularly may be at higher risk.

How to tell if you have this one

Check the product label for the NDC numbers 41167-0320-1 through 41167-0320-7. The product was distributed by Chattem, Inc., a Sanofi Company, and all lots are affected.

Brand
Sanofi
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for NDC numbers 41167-0320-1 through 41167-0320-7 on the product label.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall states that NDMA impurity was detected, but the exact health risks are not specified. The product is not recommended for use until further details are provided.

How can I get more information?

Contact Sanofi directly for more information about the recall and next steps.

What should I do if I have the product?

The recall does not specify a remedy, so contact Sanofi for guidance on what to do with the product.

Take action

Contact Sanofi

We’ve drafted a message you can send Sanofi to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall D-0538-2020 — Sanofi Sanofi

Hello,

I own a Sanofi that is covered by recall D-0538-2020 from Sanofi.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0538-2020 (October 22, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0538-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Sanofi-Aventis U.S. LLC recalls Cool Mint Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga,

Recall notice