MAJOR PHARMACEUTICALS recalls Losartan Potassium Tablets, USP. 50 mg. NDC# 0904-6390-61. Rx only. 100 count Unit Dose Cartons. Manufactured by Major
Major Pharmaceuticals recalls 50mg Losartan Potassium Tablets (NDC 0904-6390-61) due to FDA-confirmed NMBA impurity exceeding safe levels. Rx-only medication sold in 100-count unit dose cartons.
Lower-risk recall
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
Contact the company & request your remedy
What happened, in plain English
Major Pharmaceuticals is recalling 50mg Losartan Potassium Tablets (NDC 0904-6390-61) because FDA testing found an impurity (NMBA) in the product at levels above the safe limit. This could pose a health risk with long-term use. Read more at govinfonow.com/recall/39249-major-pharmaceuticals-losartan-50mg-tablets-recall-nmba-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/39249-major-pharmaceuticals-losartan-50mg-tablets-recall-nmba-impurity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1466-2019
Cite this page
“Major Pharmaceuticals Losartan 50mg Tablets Recall: NMBA Impurity Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39249-major-pharmaceuticals-losartan-50mg-tablets-recall-nmba-impurity-risk. Based on FDA recall #D-1466-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1466-2019%22&limit=1).
Why it’s dangerous
FDA lab tests found an impurity called NMBA in the Losartan tablets at levels above the acceptable daily intake. This impurity could potentially cause health issues with long-term use, though the risk is not immediate.
Who’s affected
People prescribed this medication by a doctor. Those taking the medication for high blood pressure or other conditions are most at risk.
How to tell if you have this one
Check for the NDC code 0904-6390-61 on the product label. The tablets are sold in 100-count unit dose cartons and are prescription-only.
- Brand
Major Pharmaceuticals- Category
Drug
What to do — step by step
Check Product Label
Look for the NDC code 0904-6390-61 on the tablet packaging.
Questions people ask
Is this medication safe to take?
The FDA confirmed the presence of an impurity (NMBA) at levels above the acceptable daily intake, but the risk is not immediate. Consult your doctor for guidance.
How do I know if I have the recalled product?
Check for the NDC code 0904-6390-61 on the product label. The tablets are sold in 100-count unit dose cartons and are prescription-only.
What should I do if I have the recalled product?
The recall does not specify a remedy, so contact your doctor for advice on whether to stop using the medication.
Contact Major Pharmaceuticals
We’ve drafted a message you can send Major Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-1466-2019 — Major Pharmaceuticals Major Pharmaceuticals Hello, I own a Major Pharmaceuticals that is covered by recall D-1466-2019 from Major Pharmaceuticals. 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-1466-2019 (January 10, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1466-2019 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.