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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

Granules India Limited: Ranitidine Tablets Recalled Due to NDMA Impurity

Agency Publication Date: December 29, 2019
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Summary

Granules India Limited has recalled approximately 23.1 million Ranitidine Tablets (USP 150mg), a generic medication used to treat heartburn and stomach ulcers. The recall was initiated because testing revealed the presence of N-nitrosodimethylamine (NDMA), an impurity classified as a probable human carcinogen. These prescription-strength tablets were distributed in large 10,000-count bags to distributors in Oregon, New York, and New Jersey. Consumers taking this medication should contact their doctor or pharmacist to discuss alternative treatments, as stopping the medication without a replacement could pose health risks.

Risk

The product contains NDMA, an environmental contaminant that is classified as a probable human carcinogen. While NDMA can be found in water and foods, exposure to elevated levels over a long period may increase the risk of developing cancer.

What You Should Do

  1. Check your medication packaging or contact your pharmacy to see if you have Ranitidine Tablets, USP 150mg, with NDC 62207-773-32.
  2. Verify if your medication is associated with any of the following lot numbers: 7730001A, 7730002A, 7730003A, 7730004A, 7730005A, 7730006A, 7730007A, 7730008A, 7730009A, 7730010A, 7730011A, or 7730012A.
  3. Contact your healthcare provider or pharmacist immediately for guidance. Do not stop taking your medication until you have a replacement treatment plan from a medical professional.
  4. Return any unused product to the pharmacy where it was purchased for a refund and contact Granules India Limited for further instructions regarding the disposal of the affected tablets.
  5. For additional questions, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

💰Full Refund

Pharmacy refund and healthcare consultation.

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

Affected Products

Product: RANITIDINE TABLETS, USP 150mg (10,000-count bag)
Model:
NDC 62207-773-32
Recall #: D-0632-2020
Lot Numbers:
7730001A
7730002A
7730003A
7730004A
7730005A
7730006A
7730007A
7730008A
7730009A
7730010A
7730011A
7730012A

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84522
Status: Active
Manufacturer: Granules India Limited
Sold By: Distributors in OR, NY, and NJ
Manufactured In: India
Units Affected: 23,090,000 tablets
Distributed To: Oregon, New York, New Jersey

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 · 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.