Macleods Pharma Usa Inc recalls Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90 count bottles, Rx Only, Manufactured for:
Macleods Pharma recalls 100mg/25mg losartan-hydrochlorothiazide tablets due to NDEA, a carcinogen impurity found in the active ingredient. Affected products have NDC 33342-0052-10 and lot BLM715A from July 19, 2019.
Lower-risk recall
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Contact the company & request your remedy
What happened, in plain English
Macleods Pharma is recalling 100 mg/25 mg losartan-hydrochlorothiazide tablets (Rx only) because they contain NDEA, a known carcinogen. This impurity could increase cancer risk for users taking the medication. Read more at govinfonow.com/recall/39177-macleods-pharma-losartan-hydrochlorothiazide-tablets-recall-ndea-carcinogen-impurity.
Source Summary by GovInfoNow · govinfonow.com/recall/39177-macleods-pharma-losartan-hydrochlorothiazide-tablets-recall-ndea-carcinogen-impurity · Updated October 5, 2026 · FDA enforcement record: FDA #D-1040-2019
Cite this page
“Macleods Pharma Losartan-Hydrochlorothiazide Tablets Recall: NDEA Carcinogen Impurity.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39177-macleods-pharma-losartan-hydrochlorothiazide-tablets-recall-ndea-carcinogen-impurity. 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 tablets contain NDEA, a carcinogen that forms in the body over time. This impurity was detected during manufacturing and can increase cancer risk with prolonged use.
Who’s affected
People prescribed this medication by a doctor who received the recalled tablets. Those taking the medication regularly are most at risk due to potential long-term cancer exposure.
How to tell if you have this one
Check for NDC code 33342-0052-10 and lot number BLM715A from July 19, 2019. The product is a prescription-only 90-count bottle of losartan and hydrochlorothiazide tablets.
- Brand
Macleods Pharma- Category
Drug
What to do — step by step
Check Product Details
Look for NDC code 33342-0052-10 and lot number BLM715A on the bottle label.
Questions people ask
Is this product safe to use?
The recall states the product contains a carcinogen impurity, so it is not safe for long-term use. However, the risk level is low_risk as the hazard is not immediately dangerous.
How can I get a replacement?
The recall record does not mention a replacement or remedy, so no action is required beyond checking the product details.
What is NDEA?
NDEA (N-Nitrosodimethylamine) is a known carcinogen that can increase cancer risk with prolonged exposure.
Contact Macleods Pharma
We’ve drafted a message you can send Macleods Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-1040-2019 — Macleods Pharma Macleods Pharma Hello, I own a Macleods Pharma that is covered by recall D-1040-2019 from Macleods Pharma. 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-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 qwen3:4b 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.