Macleods Pharma Usa Inc recalls Losartan Potassium Tablets 50 mg 1000 Tablets, USP Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ
Macleods Pharma USA recalls 50mg Losartan Potassium Tablets due to impurity detected in active ingredient. Prescription-only medication with NDC 33342-045-44 manufactured Nov 2019.
Recall notice
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Contact the company & request your remedy
What happened, in plain English
Macleods Pharma USA is recalling prescription Losartan Potassium Tablets 50mg (1000 tablets) because impurities were found in the active ingredient. This could pose a health risk if taken as directed. Read more at govinfonow.com/recall/38526-macleods-losartan-tablets-50mg-recall-impurity-risk-in-prescription-medication.
Source Summary by GovInfoNow · govinfonow.com/recall/38526-macleods-losartan-tablets-50mg-recall-impurity-risk-in-prescription-medication · Updated October 5, 2026 · FDA enforcement record: FDA #D-1458-2019
Cite this page
“Macleods Losartan Tablets 50mg Recall: Impurity Risk in Prescription Medication.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38526-macleods-losartan-tablets-50mg-recall-impurity-risk-in-prescription-medication. Based on FDA recall #D-1458-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1458-2019%22&limit=1).
Why it’s dangerous
The recall involves impurities in the active pharmaceutical ingredient that could be harmful when taken as medication. This impurity, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA), was detected during manufacturing and may cause health risks if the medication is used without proper medical oversight.
Who’s affected
Prescription patients who have the specific 50mg Losartan Potassium Tablets with NDC 33342-045-44 manufactured in November 2019. Those with the medication are at risk if they take it without proper medical supervision.
How to tell if you have this one
Check for the product name 'Losartan Potassium Tablets 50 mg 1000 Tablets', USP Rx Only, with NDC code 33342-045-44, manufactured in November 2019. The product was made by Macleods Pharmaceuticals in India and distributed by Macleods Pharma USA.
- Brand
Macleods- Category
Drug
All 5 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-1457-2019 | Losartan Potassium Tablets, USP 50 mg 90 tablets Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-045-10; BLI711A Nov 2019 | 47520 bottles (4,276,800 tablets) | 33342-044-10, 33342-044-12, 33342-044-07, 33342-044-44, 33342-045-10, 33342-045-12, 33342-045-07, 33342-045-44, 33342-046-10, 33342-046-12, 33342-046-07, 33342-046-44 |
| D-1458-2019 | Losartan Potassium Tablets 50 mg 1000 Tablets, USP Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-045-44; BLI710A Nov 2019 | 4277 bottles (4,277,000 tablets) | 33342-044-10, 33342-044-12, 33342-044-07, 33342-044-44, 33342-045-10, 33342-045-12, 33342-045-07, 33342-045-44, 33342-046-10, 33342-046-12, 33342-046-07, 33342-046-44 |
| D-1459-2019 | Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 90 Tablets, USP Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-050-10; BLK719A Sep-19 BLK720A Sep-19 BLK721A Sep-19 BLK722A Sep-19 BLK723A Sep-19 BLK724A Sep-19 BLK725A Oct-19 BLK726A Oct-19 BLK804A Jan-20 BLK806A Jan-20 BLK825A Oct-21 BLK826A Oct-21 | 142626 bottles (12,836,340 tablets) | 33342-050-07, 33342-050-10, 33342-050-44, 33342-050-12, 33342-051-07, 33342-051-10, 33342-051-44, 33342-051-12, 33342-052-07, 33342-052-10, 33342-052-44, 33342-052-12 |
| D-1460-2019 | Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 90 Tablets, USP Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-051-10; BLL801A Dec-19 BLL802A Dec-19 BLL803A Dec-19 | 29106 bottles (2,619,540 tablets) | 33342-050-07, 33342-050-10, 33342-050-44, 33342-050-12, 33342-051-07, 33342-051-10, 33342-051-44, 33342-051-12, 33342-052-07, 33342-052-10, 33342-052-44, 33342-052-12 |
| D-1461-2019 | Losartan Potassium andHydrochlorothiazide Tablets 100 mg/25 mg 90 tablets, USP Rx Only, Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-052-10; BLM716A Jul-19 BLM717A Jul-19 BLM719A Aug-19 BLM720A Aug-19 BLM721A Sep-19 BLM722A Sep-19 BLM723A Oct-19 BLM724A Oct-19 BLM725A Oct-19 BLM726A Nov-19 BLM802A Dec-19 BLM803A Dec-19 BLM825A Sep-21 BLM826A Sep-21 BLM827A Sep-21 | 145162 bottles (13,064,580 tablets) | 33342-050-07, 33342-050-10, 33342-050-44, 33342-050-12, 33342-051-07, 33342-051-10, 33342-051-44, 33342-051-12, 33342-052-07, 33342-052-10, 33342-052-44, 33342-052-12 |
What to do — step by step
Check Medication Details
Verify the product name, NDC code, and manufacturing date to confirm if it matches the recalled items.
Questions people ask
Is this medication safe to take?
The recall indicates impurities were found in the active ingredient, so it is not safe to take without medical supervision.
What should I do if I have this medication?
The recall does not specify a remedy, so contact your healthcare provider for guidance.
How can I confirm if my medication is recalled?
Check the NDC code (33342-045-44) and manufacturing date (November 2019) to see if it matches the recalled product.
Contact Macleods
We’ve drafted a message you can send Macleods to request your refund or repair — edit it as you like.
Subject: Recall D-1458-2019 — Macleods Macleods Hello, I own a Macleods that is covered by recall D-1458-2019 from Macleods. 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-1458-2019 (June 20, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1458-2019 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.