Sandoz, Inc recalls Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 1000-count bottles, Rx Only, Finished Drug
Sandoz recalls 1000-count bottles of Losartan Potassium and Hydrochlorothiazide tablets due to FDA-confirmed NDEA impurity exceeding safe levels. Affected lots contain a potential cancer risk.
Lower-risk recall
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Contact the company & request your remedy
What happened, in plain English
Sandoz is recalling 1000-count bottles of Losartan Potassium and Hydrochlorothiazide tablets (100 mg/25 mg) because they contain an impurity that may exceed safe levels. This impurity could pose a cancer risk if taken long-term. Read more at govinfonow.com/recall/39457-sandoz-losartan-hydrochlorothiazide-tablets-recall-ndea-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/39457-sandoz-losartan-hydrochlorothiazide-tablets-recall-ndea-impurity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0359-2019
Cite this page
“Sandoz Losartan/Hydrochlorothiazide Tablets Recall: NDEA Impurity Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39457-sandoz-losartan-hydrochlorothiazide-tablets-recall-ndea-impurity-risk. Based on FDA recall #D-0359-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0359-2019%22&limit=1).
Why it’s dangerous
The tablets contain N-nitrosodiethylamine (NDEA), a known carcinogen. FDA testing found levels of this impurity above the safe limit for daily consumption. This could increase cancer risk with long-term use.
Who’s affected
People with a prescription for these specific tablets are affected. Those taking the medication regularly are most at risk due to potential long-term exposure to the impurity.
How to tell if you have this one
Check for the product name: Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg. Look for the NDC code 0781-5207-10 and lot number JB8912 on the bottle.
- Brand
Sandoz- Category
Drug
What to do — step by step
Check Your Medication
Verify if your prescription contains the specific product name and NDC code 0781-5207-10.
Questions people ask
Is this product safe to take?
The FDA confirmed the presence of an impurity above safe levels, but the product is not safe for long-term use. Consult your doctor for alternatives.
How can I tell if I have the recalled product?
Check for the NDC code 0781-5207-10 and lot number JB8912 on the bottle label.
What should I do if I have the recalled product?
The recall does not include a specific remedy. Check with your doctor for guidance on alternative medications.
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-0359-2019 — Sandoz Sandoz Hello, I own a Sandoz that is covered by recall D-0359-2019 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-0359-2019 (November 1, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0359-2019 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.