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Lower risk Drug recall · FDA · Published March 25, 2020

Teva recalls 50mg losartan potassium tablets due to impurity risk

Teva Pharmaceuticals USA recalls 50mg losartan potassium tablets (NDC 0591-3746-00) manufactured in Malta with impurity NMBA detected in active ingredient. This is for further manufacturing, not for end consumers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-1101-2020DrugTeva Pharmaceuticals USA ›
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Recalling firmTeva Pharmaceuticals USA400 Interpace Pkwy · Parsippany, NJ 07054-1120
✎ GovInfoNow plain-language explainer

Teva Pharmaceuticals USA is recalling 50mg losartan potassium tablets used for manufacturing, not for end consumers. The tablets contain an impurity that could pose a risk during production but not for patients taking the medication. Read more at govinfonow.com/recall/37215-teva-recalls-50mg-losartan-potassium-tablets-due-to-impurity-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/37215-teva-recalls-50mg-losartan-potassium-tablets-due-to-impurity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1101-2020

Cite this page

“Teva recalls 50mg losartan potassium tablets due to impurity risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37215-teva-recalls-50mg-losartan-potassium-tablets-due-to-impurity-risk. Based on FDA recall #D-1101-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1101-2020%22&limit=1).

The FDA announced on March 25, 2020, that Teva Pharmaceuticals USA is recalling Losartan Potassium Tablets, USP 50 mg, Bulk due to CGMP deviations involving detected impurities. The agency classified the recall as Class II.

How to tell if you have it

  • Brand: Teva Pharmaceuticals USA
  • Product: LOSARTAN POTASSIUM TABLETS, USP 50 mg, Bulk
  • NDC: 0591-3746-00
  • Lots: 1195625A, 1195624A, 1195623A
  • Expiration date: 03/2020
  • Manufacturer: Arrow Pharma (Malta) Ltd.
  • Distribution: One re-packager in California

The hazard

The recall addresses CGMP deviations where the impurity N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) was detected in the active pharmaceutical ingredient used to manufacture finished products.

Context

GovInfoNow's records show Teva Pharmaceuticals USA has 97 other recalls on record since October 11, 2013. Recent brand recalls include failed dissolution risks for Doxylamine Succinate Tablets and Tretinoin Capsules in January 2022, and a mislabeling hazard for Mimvey Tablets on January 7, 2022. Other recent recalls of similar products include Teva's recall of traZODone 50mg tablets with foreign tablets risk (August 24, 2026), the Clonidine Transdermal System Recall due to unapproved raw material risk (March 19, 2026), and Claravis 10mg recalls due to impurity issues (April 6, 2026).

How to tell if you have this one

Look for losartan potassium tablets labeled 50 mg, NDC 0591-3746-00, manufactured by Arrow Pharma (Malta) Ltd. in Malta with lots 1195623A, 1195624A, or 1195625A, expiring March 2020. These tablets are for further manufacturing, not for end consumer use.

  • Brand
    Teva Pharmaceuticals USA
  • Category
    Drug
FDA recall event · 3 products

All 3 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
    Bulk product was distributed to one re-packager in California.
Recall numberProduct, codes & lots
D-1100-2020LOSARTAN POTASSIUM TABLETS, USP 25 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia Malta NDC 0591-3745-00; Lots 1207344A, exp. date 06/2020; 1207343A, 1207342A, exp. date 07/2020
D-1101-2020LOSARTAN POTASSIUM TABLETS, USP 50 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia, Malta NDC 0591-3746-00; Lots 1195625A, 1195624A, 1195623A, exp. date 03/2020
D-1102-2020LOSARTAN POTASSIUM TABLETS, USP 100 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia, Malta NDC 0591-3747-00; 1178533A, 1178534A, 1178535A, 1178536A, 1178537A, 1178538A, 1178539A, 1178540A, 1178541A, 1178542A, 1178543A, 1178544A, 1178545A, 1178546A exp 03/2020
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify the product label, NDC code, and expiration date to confirm if the tablets are for manufacturing use only.

Where it went and when

Where it was distributed

Distributed in California.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “Bulk product was distributed to one re-packager in California.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California.

Recall timeline

FDA published this recall 21 days after the firm started it.

1. Firm started the recall: Mar 25, 202012. FDA classified it Class II: Apr 7, 202023. Published in FDA’s Enforcement Report: Apr 15, 202032020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What should I do if I have these tablets?

Since these tablets are for manufacturing use only, end consumers do not need to take action.

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Keep exploring

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-1101-2020 (March 25, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1101-2020 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA