Direct Rx recalls Losartan Potassium 100 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC
FDA recalls Direct Rx Losartan Potassium 100mg tablets due to impurity NMBA above safe levels. Consumers with this specific product should stop using it.
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CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level per manufacturer
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What happened, in plain English
Direct Rx is recalling 100mg Losartan Potassium tablets because FDA testing found an impurity (NMBA) at levels above the safe limit. This could pose health risks if taken regularly. Read more at govinfonow.com/recall/38868-direct-rx-losartan-potassium-100mg-tablets-recall-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/38868-direct-rx-losartan-potassium-100mg-tablets-recall-impurity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0018-2021
Cite this page
“Direct Rx Losartan Potassium 100mg Tablets Recall: Impurity Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38868-direct-rx-losartan-potassium-100mg-tablets-recall-impurity-risk. Based on FDA recall #D-0018-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0018-2021%22&limit=1).
Why it’s dangerous
FDA labs detected N-Methylnitrosobutyric acid (NMBA) in the medication at levels exceeding the safe daily intake. This impurity could cause health issues if taken regularly, as it's not present in safe amounts.
Who’s affected
People who have the specific 100mg Losartan Potassium tablets with NDC 61919-952-30 and lot number 27AU1801 are affected. Prescriptions for this medication are at risk.
How to tell if you have this one
Check for the 100mg Losartan Potassium tablets with NDC code 61919-952-30 and lot number 27AU1801. These were distributed by Direct Rx in Dawsonville, GA.
- Brand
Direct Rx- Category
Drug
What to do — step by step
Stop Using It Now
Immediately stop using the recalled Losartan Potassium tablets as they contain an impurity that could cause health risks.
Questions people ask
Is this product safe to take?
No, the FDA found an impurity (NMBA) in the product at levels above the safe limit, so it is not safe to take.
What should I do if I have this product?
Stop using it immediately and contact your doctor for alternative medication options.
How can I check if I have the recalled product?
Look for the NDC code 61919-952-30 and lot number 27AU1801 on the bottle label.
Contact Direct Rx
We’ve drafted a message you can send Direct Rx to request your refund or repair — edit it as you like.
Subject: Recall D-0018-2021 — Direct Rx Direct Rx Hello, I own a Direct Rx that is covered by recall D-0018-2021 from Direct Rx. 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-0018-2021 (April 30, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0018-2021 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.