Sandoz, Inc recalls Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ Product of
Sandoz recalls 150mg ranitidine capsules due to trace N-nitrosodimethylamine (NDMA) impurity. This may pose health risks. Consumers should contact Sandoz for details.
Recall notice
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
Contact the company & request your remedy
What happened, in plain English
Sandoz is recalling 150mg ranitidine hydrochloride capsules (60-count) that were manufactured with a trace amount of an unexpected impurity called NDMA. This impurity could potentially pose health risks, so affected consumers should stop using the product and contact Sandoz for further instructions. Read more at govinfonow.com/recall/37912-sandoz-ranitidine-capsules-recall-trace-ndma-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/37912-sandoz-ranitidine-capsules-recall-trace-ndma-impurity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0127-2020
Cite this page
“Sandoz Ranitidine Capsules Recall: Trace NDMA Impurity Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37912-sandoz-ranitidine-capsules-recall-trace-ndma-impurity-risk. Based on FDA recall #D-0127-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0127-2020%22&limit=1).
Why it’s dangerous
The recall is due to a trace amount of N-nitrosodimethylamine (NDMA), an unexpected impurity found during manufacturing. NDMA is a potential carcinogen that could pose health risks with long-term exposure. However, the exact risk level is not specified in the recall notice.
Who’s affected
People who have the 150mg ranitidine hydrochloride capsules (60-count) with NDC 0781-2855-60 or HC9266, HD1865, HP9441, JK7994, JK8659. Those using prescription ranitidine for conditions like ulcers are most at risk.
How to tell if you have this one
Check for the NDC code 0781-2855-60 or the product codes HC9266, HD1865, HP9441, JK7994, JK8659. These capsules were sold in the U.S. from April 2020 to August 2021.
- Brand
Sandoz- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
U.S. Nationwide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0127-2020 | Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ Product of India NDC 0781-2855-60; HC9266 4/30/2020 HD1865 4/30/2020 HP9441 9/30/2020 JK7994 8/31/2021 JK8659 8/31/2021 | 100,314 bottles |
| D-0128-2020 | Sandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Product of India NDC 0781-2855-05; HD1862 4/30/2020 HP9438 9/30/2020 HP9439 9/30/2020 HP9440 9/30/2020 | 13,130 bottles |
| D-0129-2020 | Sandoz Ranitidine Hydrochloride Capsules 300mg 30 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Product of India NDC 0781-2865-31; HD8625 4/30/2020 HD9275 4/30/2020 HU2207 8/31/2020 HX6676 3/31/2021 HX6677 3/31/2021 | 136,788 bottles |
What to do — step by step
Stop Using Now
Immediately stop using the recalled ranitidine capsules as they contain a trace amount of NDMA.
Questions people ask
Why is this product being recalled?
The product was found to contain a trace amount of N-nitrosodimethylamine (NDMA), an unexpected impurity that could pose health risks.
How can I check if I have the recalled product?
Look for the NDC code 0781-2855-60 or the product codes HC9266, HD1865, HP9441, JK7994, JK8659 on the packaging.
What should I do if I have the recalled product?
Contact Sandoz directly for instructions on how to return or dispose of the product.
Contact Sandoz
We’ve drafted a message you can send Sandoz to request your refund or repair — edit it as you like.
Subject: Recall D-0127-2020 — Sandoz Sandoz Hello, I own a Sandoz that is covered by recall D-0127-2020 from Sandoz. 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-0127-2020 (September 23, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0127-2020 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.