Granules India Limited recalls RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32
Granules India Limited recalls 150mg RANITIDINE tablets due to N-nitrosodimethylamine (NDMA) impurity found in the manufacturing process. This impurity may pose health risks with long-term use.
Recall notice
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Contact the company & request your remedy
What happened, in plain English
Granules India Limited is recalling 150mg RANITIDINE tablets that may contain N-nitrosodimethylamine (NDMA), a potential carcinogen. This recall is due to manufacturing impurities found in the drug product. Read more at govinfonow.com/recall/37654-granules-india-limited-ranitidine-tablets-150mg-recall-ndma-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/37654-granules-india-limited-ranitidine-tablets-150mg-recall-ndma-impurity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0632-2020
Cite this page
“Granules India Limited RANITIDINE Tablets 150mg Recall: NDMA Impurity Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37654-granules-india-limited-ranitidine-tablets-150mg-recall-ndma-impurity-risk. Based on FDA recall #D-0632-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0632-2020%22&limit=1).
Why it’s dangerous
The recall is for a chemical impurity called N-nitrosodimethylamine (NDMA) that was found during manufacturing. NDMA is a potential carcinogen, meaning it could increase cancer risk with long-term exposure. The impurity was discovered in the drug's active ingredient (API) during production.
Who’s affected
People who own or use the recalled 150mg RANITIDINE tablets from Granules India Limited in India. Those with long-term use of the medication are at higher risk due to the impurity.
How to tell if you have this one
Check for the product name 'RANITIDINE TABLETS, USP 150mg', 10,000-count bag, Country of Origin: INDIA, and NDC code 62207-773-32. The specific batch numbers listed are 7730001A through 7730012A.
- Brand
Granules India Limited- Category
Drug
What to do — step by step
Check Product Details
Identify if your tablets match the product description: 150mg RANITIDINE, 10,000-count bag, India origin, NDC 62207-773-32, and batch numbers 7730001A-7730012A.
Questions people ask
Is this recall dangerous?
The recall is due to a potential carcinogen (NDMA) found in the manufacturing process. The risk depends on long-term use, but the official notice does not specify immediate danger.
How can I check if my tablets are recalled?
Check the product label for 'RANITIDINE TABLETS, USP 150mg', 10,000-count bag, India origin, NDC 62207-773-32, and batch numbers 7730001A through 7730012A.
What should I do if I have the recalled tablets?
The recall record does not specify a remedy, so you should contact the manufacturer directly for guidance.
Contact Granules India Limited
We’ve drafted a message you can send Granules India Limited to request your refund or repair — edit it as you like.
Subject: Recall D-0632-2020 — Granules India Limited Granules India Limited Hello, I own a Granules India Limited that is covered by recall D-0632-2020 from Granules India Limited. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0632-2020 (December 13, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0632-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.