Direct Rx Losartan Pot/HCTZ Recall: NMBA Impurity Risk
Direct Rx recalls specific lots of Losartan Pot/HCTZ 50/12.5 mg tablets due to trace amounts of the impurity N-Methylnitrosobutyric acid (NMBA).
Use caution until it’s fixed
CGMP deviation: Trace amounts of impurity detected to be N-Methylnitrosobutyric acid (NMBA) in the API.
Contact the company
What happened, in plain English
Direct Rx is recalling a small quantity of Losartan Pot/HCTZ 50/12.5 mg tablets because testing found trace amounts of an impurity called N-Methylnitrosobutyric acid (NMBA) in the active pharmaceutical ingredient. This recall affects only 33 bottles distributed in Florida, with a specific lot number and expiration date. The manufacturer has not yet provided a remedy or instructions for consumers. Read more at govinfonow.com/recall/39115-direct-rx-losartan-pot-hctz-recall-nmba-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/39115-direct-rx-losartan-pot-hctz-recall-nmba-impurity-risk · Updated October 11, 2026 · FDA enforcement record: FDA #D-0032-2021
Cite this page
“Direct Rx Losartan Pot/HCTZ Recall: NMBA Impurity Risk.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/39115-direct-rx-losartan-pot-hctz-recall-nmba-impurity-risk. Based on FDA recall #D-0032-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0032-2021%22&limit=1).
Why it’s dangerous
The presence of N-Methylnitrosobutyric acid (NMBA) in the drug's active ingredient represents a deviation from Current Good Manufacturing Practices (CGMP). While NMBA is an impurity that can be harmful, the record does not specify the severity of injury or long-term health effects associated with this specific trace amount.
Who’s affected
Individuals in Florida who purchased this specific medication from Direct Rx between the manufacturing date and the recall announcement on March 12, 2019. The risk is limited to those holding the specific lot number listed below.
How to tell if you have this one
Check your medication bottle for the following details: Brand 'Direct Rx', Product 'Losartan Pot/HCTZ 50/12.5 mg 90 Tabs', NDC '61919-040-90', Lot number '12DE1806', and Expiration date '01/31/2021'. The product was packaged by Direct Rx in Dawsonville, GA, and manufactured for Torrent Pharma.
- Brand
Direct Rx- Category
Drug
What to do — step by step
Check Your Medication
Verify if your bottle matches the NDC, lot number, and expiration date listed in the recall record.
Contact Direct Rx
Since no remedy is currently stated, contact Direct Rx directly for instructions on how to handle this specific lot.
Where it went and when
Where it was distributed
Distributed in Florida.
FDA distribution: “FL” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida.
Recall timeline
FDA terminated this recall 2.5 years after the firm started it.
- Firm started the recall
- Published in FDA’s Enforcement Report
- FDA classified it Class II
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
When does the recalled medication expire?
The expiration date for the recalled product is January 31, 2021.
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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-0032-2021 (March 12, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0032-2021 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.