Teva recalls Losartan Potassium 50mg tablets with impurity risk
Teva Pharmaceuticals USA recalls Losartan Potassium 50mg tablets due to impurity detected in active ingredient. Affected lots may pose health risks. Consumers should check product details and contact Teva for guidance.
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
What happened, in plain English
Teva Pharmaceuticals USA is recalling Losartan Potassium 50mg tablets (NDC 00591-3746-00) because impurities were found in the active ingredient. This could potentially cause health issues if taken by people with certain conditions. Read more at govinfonow.com/recall/38722-teva-recalls-losartan-potassium-50mg-tablets-with-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/38722-teva-recalls-losartan-potassium-50mg-tablets-with-impurity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1455-2019
Cite this page
“Teva recalls Losartan Potassium 50mg tablets with impurity risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38722-teva-recalls-losartan-potassium-50mg-tablets-with-impurity-risk. Based on FDA recall #D-1455-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1455-2019%22&limit=1).
Why it’s dangerous
The recall is for impurities in the active pharmaceutical ingredient (API) used to make the tablets. These impurities, specifically N-Nitroso-N-methyl-4-aminobutyric acid (NMBA), could cause health problems if the medication is taken.
Who’s affected
People who have purchased Losartan Potassium 50mg tablets from Teva in the US. Those with kidney issues or on specific medications may be at higher risk.
How to tell if you have this one
Check for NDC 00591-3746-00 on the product label. Look for specific lot numbers: 1169752A (1000 tablets), 1169753A (90 tablets), GS017387, GS017651, or GS017479 with expiration dates of January 2020.
- Brand
Teva- Category
Drug
All 2 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
Ongoing- Distribution
Nationwide by 4 major distributors.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1455-2019 | LOSARTAN POTASSIUM 50 mg TABLET BULK 90 count bottles and 1000 count bottles, NDC 00591-3746-00; Arrow Malta (Teva) Bulk Product Lot # 1169752A, exp. date 01/2020, 1000 tablets/bottle 1169753A, exp. date 01/2020, 90 tablets/bottle Golden State Medical Finished Product Lot # GS017387, exp. date 01/2020 GS017651, exp. date 01/2020 GS017479, exp. date 01/2020 | 2,924,000 tablets |
| D-1456-2019 | LOSARTAN POTASSIUM 100 mg TABLET BULK 90 count bottles, NDC 00591-3747-00; Arrow Malta (Teva) Bulk Product Lot # 1163892A, exp. date 01/2020 1163893A, exp. date 01/2020 1163894A, exp. date 01/2020 1163895A, exp. date 01/2020 Golden State Medical Finished Product Lot # GS017042, exp. date 01/2020 GS017043, exp. date 01/2020 GS017044, exp. date 01/2020 GS017541, exp. date 01/2020 | 2,943,000 tablets |
What to do — step by step
Check Product Details
Look for NDC 00591-3746-00, lot numbers 1169752A, 1169753A, GS017387, GS017651, or GS017479, and expiration dates of January 2020.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide by 4 major distributors.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 41 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
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-1455-2019 (June 6, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1455-2019 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.