Macleods Pharma Usa Inc recalls Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg, 30, 90 & 1000 count NDC # 33342-052-07, NDC
Macleods Pharma recalls Losartan-Hydrochlorothiazide tablets due to AZIDO impurity levels exceeding safety limits. Affected lots may pose health risks if taken.
Recall notice
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Contact the company & request your remedy
What happened, in plain English
Macleods Pharma is recalling Losartan potassium and Hydrochlorothiazide tablets that contain unsafe levels of an AZIDO impurity. This could cause health risks if taken as prescribed. Read more at govinfonow.com/recall/34630-macleods-pharma-losartan-hydrochlorothiazide-tablets-recall-azido-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/34630-macleods-pharma-losartan-hydrochlorothiazide-tablets-recall-azido-impurity-risk · Updated September 23, 2026 · FDA enforcement record: FDA #D-1164-2022
Cite this page
“Macleods Pharma Losartan-Hydrochlorothiazide Tablets Recall: AZIDO Impurity Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/34630-macleods-pharma-losartan-hydrochlorothiazide-tablets-recall-azido-impurity-risk. Based on FDA recall #D-1164-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1164-2022%22&limit=1).
Why it’s dangerous
The tablets contain an AZIDO impurity at levels above what is safe. This impurity could potentially cause health issues if the medication is taken as directed.
Who’s affected
People who have the specific lot numbers of these tablets (NDC #33342-052-07, -10, -44) and are prescribed this medication. Those taking the medication for blood pressure or other conditions are most at risk.
How to tell if you have this one
Check the product label for the specific lot numbers: NDC #33342-052-07, -10, or -44. The tablets are prescription-only and come in 30, 90, or 1000-count packages.
- Brand
Macleods Pharma- Category
Drug
What to do — step by step
Check Product Label
Look for the lot numbers NDC #33342-052-07, -10, or -44 on the tablet packaging.
Questions people ask
What is the specific impurity in the recalled medication?
The recall is due to AZIDO impurity levels exceeding acceptable limits, but the exact nature of the impurity is not specified in the notice.
Do I need to stop taking these tablets?
The recall notice does not specify a stop-use instruction; it only identifies affected lots.
How can I confirm if my tablets are affected?
Check the product label for the lot numbers NDC #33342-052-07, -10, or -44.
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-1164-2022 — Macleods Pharma Macleods Pharma Hello, I own a Macleods Pharma that is covered by recall D-1164-2022 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.
Similar recalls
Keep exploring
From people who’ve dealt with this
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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-1164-2022 (June 10, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1164-2022 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 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.