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Use caution Drug recall · FDA · Published May 7, 2024

Macleods Losartan/HCTZ Recall: Foreign Substance Hazard

Macleods Pharma recalls 1048 bottles of Losartan Potassium and Hydrochlorothiazide tablets due to a plastic-like foreign substance. Check your lot number.

🇺🇸 FDA recall #D-0498-2024DrugMacleods Pharma USA ›
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Recalling firmMACLEODS PHARMA USA, INC103 College Rd E Fl 2 · Princeton, NJ 08540-6611
✎ GovInfoNow plain-language explainer

What happened, in plain English

Macleods Pharma USA, Inc. is recalling one specific lot of Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg/12.5 mg because they contain a foreign plastic-like substance. The recall affects 1,048 bottles distributed nationwide in the United States. This is classified as a Class II recall. Read more at govinfonow.com/recall/32691-macleods-losartan-hctz-recall-foreign-substance-hazard.

Source Summary by GovInfoNow · govinfonow.com/recall/32691-macleods-losartan-hctz-recall-foreign-substance-hazard · Updated October 9, 2026 · FDA enforcement record: FDA #D-0498-2024

Cite this page

“Macleods Losartan/HCTZ Recall: Foreign Substance Hazard.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/32691-macleods-losartan-hctz-recall-foreign-substance-hazard. Based on FDA recall #D-0498-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0498-2024%22&limit=1).

Why it’s dangerous

The presence of a plastic-like foreign substance in the medication poses a physical hazard if ingested. While the record does not specify the exact injury mechanism, consuming non-food items found in pharmaceuticals is generally unsafe and requires medical attention.

Who’s affected

Patients who have been prescribed Losartan Potassium and Hydrochlorothiazide Tablets by this manufacturer are affected. Individuals who purchased or possess the specific lot identified in the record are at risk of ingesting the foreign substance.

How to tell if you have this one

Check your bottle for NDC 33342-050-44 and Lot # BLK2304A with an expiration date of 07/31/2025. The product is a 1000-count bottle of Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg/12.5 mg.

  • Brand
    Macleods Pharma USA
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check your medication

    Verify if your bottle matches NDC 33342-050-44 and Lot # BLK2304A with expiration date 07/31/2025.

  2. Contact your pharmacist

    Speak with your healthcare provider or pharmacist to determine the next steps for replacement or disposal, as the remedy details are not provided in this record.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “USA Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 15 days after the firm started it.

1. Firm started the recall: May 7, 202412. FDA classified it Class II: May 15, 202423. Published in FDA’s Enforcement Report: May 22, 202432024
  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.

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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-0498-2024 (May 7, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0498-2024 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 9, 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