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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/Prescription Drugs

Preferred Pharmaceuticals, Inc: Ranitidine Tablets Recalled for NDMA Impurity

Agency Publication Date: January 20, 2020
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Summary

Preferred Pharmaceuticals, Inc. has recalled approximately 260,882 units of Ranitidine Tablets (150 mg and 300 mg) because an impurity called N-nitrosodimethylamine (NDMA) was detected in the product. This medication is typically used to treat heartburn and stomach ulcers. Consumers should check their medicine cabinets for the affected bottles, which include 14, 30, 60, 90, and 100-count sizes sold across several states. Because this is a medication recall, you should consult with your healthcare provider or pharmacist regarding the safety of your current prescription and to discuss alternative treatments.

Risk

The product contains NDMA, a substance that is classified as a probable human carcinogen. Long-term exposure to levels above acceptable limits may increase the risk of developing cancer.

What You Should Do

  1. Check your medication bottles for Ranitidine Tablets 150 mg (NDC numbers 68788-7388-3, 68788-7388-6, 68788-7388-9, 68788-7388-1) or Ranitidine Tablets 300 mg (NDC numbers 68788-6382-1, 68788-6382-3, 68788-6382-9, 68788-6382-0).
  2. Verify if your bottle belongs to 'All lots within expiry' as the entire current stock is being recalled due to the manufacturing deviation.
  3. Contact your healthcare provider or pharmacist immediately to discuss your treatment and determine if you should stop taking the medication or switch to an alternative.
  4. Return any unused product to the pharmacy or place of purchase to receive a refund.
  5. Contact Preferred Pharmaceuticals, Inc. at their Anaheim, California location for further instructions regarding the return process.
  6. For additional questions or to report a complaint, call 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

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

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

Affected Products

Product: Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 150 mg (30 count bottle)
Model:
NDC: 68788-7388-3
Recall #: D-0796-2020
Lot Numbers:
All lots within expiry
Product: Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 150 mg (60 count bottle)
Model:
NDC: 68788-7388-6
Recall #: D-0796-2020
Lot Numbers:
All lots within expiry
Product: Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 150 mg (90 count bottle)
Model:
NDC: 68788-7388-9
Recall #: D-0796-2020
Lot Numbers:
All lots within expiry
Product: Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 150 mg (100 count bottle)
Model:
NDC: 68788-7388-1
Recall #: D-0796-2020
Lot Numbers:
All lots within expiry
Product: Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 300 mg, Rx Only (14 count bottle)
Model:
NDC: 68788-6382-1
Recall #: D-0797-2020
Lot Numbers:
All lots within expiry
Product: Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 300 mg, Rx Only (30 count bottle)
Model:
NDC: 68788-6382-3
Recall #: D-0797-2020
Lot Numbers:
All lots within expiry
Product: Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 300 mg, Rx Only (90 count bottle)
Model:
NDC: 68788-6382-9
Recall #: D-0797-2020
Lot Numbers:
All lots within expiry
Product: Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 300 mg, Rx Only (100 count bottle)
Model:
NDC: 68788-6382-0
Recall #: D-0797-2020
Lot Numbers:
All lots within expiry

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84671
Status: Resolved
Manufacturer: Preferred Pharmaceuticals, Inc
Sold By: physicians
Manufactured In: United States
Units Affected: 2 products (221,710 tablets; 39,172 tablets)
Distributed To: Alabama, Arizona, California, Florida, Georgia, Indiana, South Carolina

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.