Macleods Losartan/HCTZ Recall: NDEA Impurity Risk
Macleods Pharma recalls 90-count bottles of Losartan Potassium and Hydrochlorothiazide tablets due to carcinogen impurity. Check your lot number.
Stop using this now
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
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What happened, in plain English
Macleods Pharma USA is recalling one lot of Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg in 90-count bottles. The recall is due to a Current Good Manufacturing Practice (CGMP) deviation where the carcinogen impurity NDEA was detected in the active ingredient. This specific lot was distributed in New Jersey, New York, and Florida. Read more at govinfonow.com/recall/39177-macleods-losartan-hctz-recall-ndea-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/39177-macleods-losartan-hctz-recall-ndea-impurity-risk · Updated October 11, 2026 · FDA enforcement record: FDA #D-1040-2019
Cite this page
“Macleods Losartan/HCTZ Recall: NDEA Impurity Risk.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/39177-macleods-losartan-hctz-recall-ndea-impurity-risk. Based on FDA recall #D-1040-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1040-2019%22&limit=1).
Why it’s dangerous
The product contains NDEA (N-Nitrosodimethylamine), which is identified as a carcinogen impurity. Exposure to this substance poses a potential long-term health risk associated with cancer development.
Who’s affected
Patients who have been prescribed Losartan Potassium and Hydrochlorothiazide Tablets manufactured by Macleods Pharmaceuticals Ltd. for Macleods Pharma USA, Inc. Those who purchased or were dispensed the specific lot BLM715A are at risk.
How to tell if you have this one
Check your medication bottle for the National Drug Code (NDC) 33342-0052-10 and Lot number BLM715A. The product is Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, in 90-count bottles marked Rx Only.
- Brand
Macleods Pharma- Category
Drug
What to do — step by step
Stop taking the medication
Do not consume any tablets from the recalled lot until you have consulted your healthcare provider for alternative treatment options.
Contact your pharmacist or doctor
Reach out to the pharmacy where you filled the prescription or your prescribing physician to report the recall and obtain a replacement prescription if necessary.
Where it went and when
Where it was distributed
Distributed in 3 states.
FDA distribution: “NJ, NY, FL” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida, New Jersey, New York.
Recall timeline
FDA terminated this recall 19 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-1040-2019 (February 21, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1040-2019 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.