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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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

Apotex Inc.: Ranitidine Acid Reducer Tablets Recalled for Possible NDMA Contamination

Agency Publication Date: November 12, 2019
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Summary

Apotex Inc. has voluntarily recalled over 1.8 million bottles of various ranitidine hydrochloride tablets, including store brands for Walgreens, Walmart (Equate), and Rite Aid. These products, commonly used as acid reducers for heartburn relief, were manufactured with potential deviations from good manufacturing practices. Specifically, there is a risk that the tablets contain an impurity called N-nitrosodimethylamine (NDMA). No injuries or adverse events have been reported to date for these products, which were distributed nationwide in the United States.

Risk

The tablets may contain N-nitrosodimethylamine (NDMA), which is classified as a probable human carcinogen. Long-term exposure to levels of NDMA above acceptable limits could potentially increase the risk of cancer.

What You Should Do

  1. Identify if you have the affected product by checking the label for the following brands and NDC numbers: Walgreens Wal-Zan 150 (NDC 0363-1030-07, 0363-1030-02, 0363-1030-09, 0363-1030-06), Walgreens Wal-Zan 75 (NDC 0363-1029-03), Equate Maximum Strength (NDC 49035-100-07, 49035-100-00, 49035-117-06), or Rite Aid Pharmacy Maximum Strength (NDC 11822-6107-4, 11822-6052-1, 11822-6052-2, 11822-4727-3, 11822-6051-8).
  2. Check the expiration date on the bottle; this recall affects all lots of the listed products that are currently within their expiration date.
  3. Contact your healthcare provider or pharmacist for guidance on alternative treatments and whether you should continue using your current supply.
  4. Return any unused product to the pharmacy or retail store where it was purchased for a full refund.
  5. Contact Apotex Inc. for further instructions or to report concerns by calling 1-800-706-5575 or visiting their website.
  6. For additional questions or to report a safety 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

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

Affected Products

Product: Walgreens Maximum Strength Wal-Zan 150 Ranitidine Tablets, USP 150 mg/Acid Reducer (200, 24, 95, or 65 Tablets)
Model:
NDC 0363-1030-07
NDC 0363-1030-02
NDC 0363-1030-09
NDC 0363-1030-06
Lot Numbers:
All lots remaining within expiry
Product: Walgreens Regular Strength Wal-Zan 75 Ranitidine Tablets, USP 75 mg/Acid Reducer (30 Tablets)
Model:
NDC 0363-1029-03
Lot Numbers:
All lots remaining within expiry
Product: Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer (130 Tablets/Twin Pack or Single Pack)
Model:
NDC 49035-100-07
NDC 49035-100-00
Lot Numbers:
All lots remaining within expiry
Product: Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg Cool Mint Acid Reducer (24 Tablets)
Model:
NDC 11822-6107-4
Lot Numbers:
All lots remaining within expiry
Product: Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer Cool Mint Tablets (65 Tablets)
Model:
NDC 49035-117-06
Lot Numbers:
All lots remaining within expiry
Product: Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg-acid reducer (50, 65, 95, or 24 Tablets)
Model:
NDC 11822-6052-1
NDC 11822-6052-2
NDC 11822-4727-3
NDC 11822-6051-8
Lot Numbers:
All lots remaining within expiry

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83871
Status: Resolved
Manufacturer: Apotex Inc.
Sold By: Walgreens; Walmart; Rite Aid
Manufactured In: Canada
Units Affected: 6 products (259,647 bottles; 42,873 bottles; 1,132,453 bottles; 31,968 bottles; 162,344 bottles; 215,387 bottles)
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.