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Medium RiskFDA Drug
Medications & Supplements/Over-the-Counter

Sanofi-Aventis U.S. LLC: Various Zantac Products Recalled Due to NDMA Impurity

Agency Publication Date: December 2, 2019
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Summary

Sanofi-Aventis U.S. LLC has voluntarily recalled all lots of various Zantac (ranitidine) products, including Regular Strength 75 mg, Maximum Strength 150 mg, and Cool Mint variants. The recall was initiated because the product may contain N-nitrosodimethylamine (NDMA), an impurity classified as a probable human carcinogen. Consumers who have these products should contact their healthcare provider or pharmacist for guidance on alternative treatments and return the items to the place of purchase for a refund.

Risk

The product was found to contain NDMA, a substance that is suspected of causing cancer in humans based on laboratory tests. While NDMA is a common environmental contaminant found in water and foods, its presence in a medication at unexpected levels poses a potential long-term health risk.

What You Should Do

  1. Check your medicine cabinet for any Zantac (ranitidine) products, specifically Regular Strength 75 mg, Maximum Strength 150 mg, or Cool Mint Maximum Strength 150 mg tablets.
  2. Identify if your product is affected by matching the National Drug Code (NDC) on the packaging to these numbers: 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, 41167-0300-0, 41167-0300-1, 41167-0300-3, 41167-0300-5, 41167-0300-6, 41167-0300-7, 41167-0300-8, 41167-0310-1, 41167-0310-2, 41167-0310-3, 41167-0310-4, 41167-0310-6, 41167-0310-7, 41167-0310-8, 05269-220-25, 41167-0320-1, 41167-0320-2, 41167-0320-3, 41167-0320-4, 41167-0320-5, 41167-0320-6, 41167-0320-7, 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, 50269-222-25, 67751-151-01, 67751-152-01, 67751-152-02, 68151-2584-0, 66715-9736-2, 66715-9736-3, 66715-9736-8, 0597-0122-01, 0597-0122-08, 0597-0122-13, 0597-0122-37, 0597-0122-40, 0597-0122-54, 0597-0122-61, 0597-0122-81, and 0597-0122-96. All lot numbers for these codes are included in the recall.
  3. Contact your healthcare provider or pharmacist to discuss your treatment options and find a suitable alternative for your acid reflux or heartburn medication.
  4. Return any unused portions of the affected Zantac products to the pharmacy or retail store where you purchased them for a full refund.
  5. For further questions or to report a concern, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Full refund upon return of product.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Cool Mint Tablets Maximum Strength Zantac 150 mg
Model:
NDC 0597-0120-06
NDC 0597-0120-08
NDC 0597-0120-09
NDC 0597-0120-24
NDC 0597-0120-38
NDC 0597-0120-50
NDC 0597-0120-76
NDC 0597-0120-78
NDC 0597-0120-80
NDC 0597-0120-82
NDC 0597-0120-87
Lot Numbers:
all lots
Product: Regular Strength Zantac 75 mg
Model:
NDC 41167-0300-0
NDC 41167-0300-1
NDC 41167-0300-3
NDC 41167-0300-5
NDC 41167-0300-6
NDC 41167-0300-7
NDC 41167-0300-8
Lot Numbers:
all lots
Product: Maximum Strength Zantac 150 mg
Model:
NDC 41167-0310-1
NDC 41167-0310-2
NDC 41167-0310-3
NDC 41167-0310-4
NDC 41167-0310-6
NDC 41167-0310-7
NDC 41167-0310-8
Lot Numbers:
all lots
Product: Regular Strength Zantac 150 mg
Model:
NDC 05269-220-25
Lot Numbers:
all lots
Product: Cool Mint Maximum Strength Zantac 150 mg
Model:
NDC 41167-0320-1
NDC 41167-0320-2
NDC 41167-0320-3
NDC 41167-0320-4
NDC 41167-0320-5
NDC 41167-0320-6
NDC 41167-0320-7
Lot Numbers:
all lots
Product: Maximum Strength Zantac 150 mg
Model:
NDC 0597-0121-01
NDC 0597-0121-06
NDC 0597-0121-08
NDC 0597-0121-09
NDC 0597-0121-11
NDC 0597-0121-24
NDC 0597-0121-38
NDC 0597-0121-50
NDC 0597-0121-64
NDC 0597-0121-66
NDC 0597-0121-68
NDC 0597-0121-78
NDC 0597-0121-80
NDC 0597-0121-82
NDC 0597-0121-85
NDC 0597-0121-90
NDC 0597-0121-94
Lot Numbers:
all lots
Product: Regular Strength Zantac 75 mg
Model:
NDC 50269-222-25
Lot Numbers:
all lots
Product: Regular Strength Zantac 150 mg
Model:
NDC 67751-151-01
Lot Numbers:
all lots
Product: Regular Strength Zantac 75 mg (67751)
Model:
NDC 67751-152-01
NDC 67751-152-02
Lot Numbers:
all lots
Product: Regular Strength Zantac 75 mg (68151)
Model:
NDC 68151-2584-0
Lot Numbers:
all lots
Product: Zantac 150 mg
Model:
NDC 66715-9736-2
NDC 66715-9736-3
NDC 66715-9736-8
Lot Numbers:
all lots
Product: Zantac 75 mg
Model:
NDC 0597-0122-01
NDC 0597-0122-08
NDC 0597-0122-13
NDC 0597-0122-37
NDC 0597-0122-40
NDC 0597-0122-54
NDC 0597-0122-61
NDC 0597-0122-81
NDC 0597-0122-96
Lot Numbers:
all lots

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84122
Status: Active
Manufacturer: Sanofi-Aventis U.S. LLC
Sold By: Chattem, Inc.; pharmacies nationwide
Manufactured In: United States
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.