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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

RemedyRepack Inc.: Ranitidine 150 mg Tablets Recalled for Potential NDMA Contamination

Agency Publication Date: January 20, 2020
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Summary

RemedyRepack Inc. is recalling 4,486 tablets of Ranitidine (150 mg), a medication commonly used to treat and prevent heartburn and stomach ulcers. This recall was issued after the supplier notified the company that the tablets may contain N-Nitrosodimethylamine (NDMA) at levels higher than what is considered safe. Approximately 4,486 tablets were affected and distributed to medical facilities in California and New York. If you are taking this medication, you should consult with a healthcare professional or pharmacist to find an alternative treatment and return any unused portions of the affected drug for a refund.

Risk

NDMA is classified as a probable human carcinogen, meaning it is a substance that could increase the risk of cancer following long-term exposure to levels above acceptable limits.

What You Should Do

  1. Check your medication label for the product name Ranitidine 150 mg and the repackaged NDC number 70518-1714-00.
  2. Verify if your medication belongs to one of the following affected lots: J0376034-052319 (Exp 05/2020), J0406133-093019 (Exp 10/2020), J038005-082719 (Exp 08/2020), J0390280-072519 (Exp 07/2020), J0390277-072519 (Exp 07/2020), or J0349352-012519 (Exp 01/2020).
  3. Contact your healthcare provider or pharmacist immediately to discuss your treatment options and obtain a replacement prescription before you stop taking the recalled medication.
  4. Return any unused tablets to the pharmacy or facility where you received them to request a refund.
  5. For further questions regarding this recall, contact RemedyRepack Inc. at their facility located at 625 Kolter Dr Ste 4, Indiana, PA 15701-3571.
  6. For additional assistance or to report a problem, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Return for refund

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

Affected Products

Product: Ranitidine 150 mg tablet
Model:
NDC 70518-1714-00
NDC 65162-0253-10
Lot Numbers:
J0376034-052319 (Exp 05/2020)
J0406133-093019 (Exp 10/2020)
J038005-082719 (Exp 08/2020)
J0390280-072519 (Exp 07/2020)
J0390277-072519 (Exp 07/2020)
J0349352-012519 (Exp 01/2020)
Date Ranges: Expiration Date 05/2020, Expiration Date 10/2020, Expiration Date 08/2020, Expiration Date 07/2020, Expiration Date 01/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84696
Status: Resolved
Manufacturer: RemedyRepack Inc.
Manufactured In: United States
Units Affected: 4,486 tablets
Distributed To: California, New York

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.