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Drug recall · FDA · Published October 22, 2019

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

Sanofi recalls Cool Mint Zantac 150mg tablets due to detected NDMA impurity. Affected products include specific NDC codes and all lots. Consumers should check their product labels and contact Sanofi for details.

Plain-English summary generated from official FDA data by GovInfoNow · How we make summaries

🇺🇸 FDA recall #D-0534-2020DrugSanofi ›
Take action

Contact the company & request your remedy

Recalling firmSanofi-Aventis U.S. LLC55 Corporate Dr · Bridgewater, NJ 08807-1265
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
✎ GovInfoNow plain-language explainer

What happened, in plain English

Sanofi is recalling Cool Mint Zantac 150mg tablets after finding NDMA impurities in the product. This impurity could pose health risks, so affected consumers should stop using the product and contact Sanofi for guidance. Read more at govinfonow.com/recall/37802-sanofi-cool-mint-zantac-150mg-tablets-recall-ndma-impurity-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/37802-sanofi-cool-mint-zantac-150mg-tablets-recall-ndma-impurity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0534-2020

Cite this page

“Sanofi Cool Mint Zantac 150mg Tablets Recall: NDMA Impurity Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37802-sanofi-cool-mint-zantac-150mg-tablets-recall-ndma-impurity-risk. Based on FDA recall #D-0534-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0534-2020%22&limit=1).

Why it’s dangerous

NDMA (N-Nitrosodimethylamine) is a potential carcinogen that can form in certain chemical processes. The presence of this impurity in the tablets may pose health risks, though the exact risk level is not fully specified in the recall notice.

Who’s affected

People who own or use Cool Mint Zantac 150mg tablets with the listed NDC codes are affected. Those who have taken the product recently may be at higher risk due to the impurity.

How to tell if you have this one

Check the product label for the NDC codes listed: 0597-0120-06, 0597-0120-08, 0597-0120-09, 0597-0120-24, 0597-0120-38, 0597-0120-50, 0597-0120-76, 0597-0120-78, 0597-0120-80, 0597-0120-82, 0597-0120-87. All lots of these products are affected.

  • Brand
    Sanofi
  • Category
    Drug
FDA recall event · 12 products

All 12 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    Nationwide
Recall numberProduct, codes & lotsQuantity
D-0534-2020Cool Mint Tablets Maximum Strength Zantac 150 mg Sanofi Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's: 0597-0120-06, 0597-0120-08, 0597-0120-09, 0597-0120-24, 0597-0120-38, 0597-0120-50, 0597-0120-76, 0597-0120-78, 0597-0120-80, 0597-0120-82, 0597-0120-87.; all lots—
D-0535-2020Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219 NDC's 41167-0300-0, 41167-0300-1, 41167-0300-3, 41167-0300-5, 41167-0300-6, 41167-0300-7, 41167-0300-8; all lots—
D-0536-2020Maximum Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 41167-0310-1 41167-0310-2 41167-0310-3 41167-0310-4 41167-0310-6 41167-0310-7 41167-0310-8; all lots—
D-0537-2020Regular Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 05269-220-25.; all lots—
D-0538-2020Cool Mint Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219 NDC's: 41167-0320-1 41167-0320-2 41167-0320-3 41167-0320-4 41167-0320-5 41167-0320-6 41167-0320-7; all lots—
D-0539-2020Maximum 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, 0597-0121-66, 0597-0121-68, 0597-0121-78, 0597-0121-80, 0597-0121-82, 0597-0121-85, 0597-0121-90, 0597-0121-94.; all lots—
D-0540-2020Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 50269-222-25.; all lots—
D-0541-2020Regular Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 67751-151-01.; all lots—
D-0542-2020Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 67751-152-01 67751-152-02; all lots—
D-0543-2020Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 68151-2584-0.; all lots—
D-0544-2020Zantac 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; all lots—
D-0545-2020Zantac 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; all lots—
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Look for the NDC codes listed in the recall notice to confirm if your product is affected.

  2. Stop Using Product

    If your product has the listed NDC codes, stop using it immediately.

  3. Contact Sanofi

    Reach out to Sanofi for further instructions or to get replacement options.

✎ GovInfoNow

Questions people ask

What is the specific impurity in the recalled Zantac tablets?

The recall mentions NDMA (N-Nitrosodimethylamine) impurity, but does not specify the exact levels or health risks.

How can I check if my Zantac tablet is affected?

Check the product label for the NDC codes listed: 0597-0120-06, 0597-0120-08, 0597-0120-09, 0597-0120-24, 0597-0120-38, 0597-0120-50, 0597-0120-76, 0597-0120-78, 0597-0120-80, 0597-0120-82, 0597-0120-87.

Do I need to return the product?

The recall does not specify a return process, but you should contact Sanofi for instructions.

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-0534-2020 — Sanofi Sanofi

Hello,

I own a Sanofi that is covered by recall D-0534-2020 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-0534-2020 (October 22, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0534-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on October 5, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA