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Unrated Drug recall · FDA · Published June 20, 2025

Lupin Lisinopril/Hydrochlorothiazide Tablets Recall: Foreign Tablets Found

Lupin Pharmaceuticals recalls 20mg/12.5mg lisinopril and hydrochlorothiazide tablets due to foreign tablets found in sealed bottles. This product is for prescription use only.

🇺🇸 FDA recall #D-0532-2025DrugLupin Pharmaceuticals ›
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Recalling firmLupin Pharmaceuticals Inc.5801 Pelican Bay Blvd, Suite 500 · Naples, FL 34108-2755
✎ GovInfoNow plain-language explainer

Lupin Pharmaceuticals is recalling 100-count bottles of lisinopril and hydrochlorothiazide tablets (20mg/12.5mg) because a sealed bottle was found to contain foreign tablets (atazanavir and ritonavir). This could be dangerous as the foreign tablets are prescription medications that may cause harm if taken. Read more at govinfonow.com/recall/32014-lupin-lisinopril-hydrochlorothiazide-tablets-recall-foreign-tablets-found.

Source Summary by GovInfoNow · govinfonow.com/recall/32014-lupin-lisinopril-hydrochlorothiazide-tablets-recall-foreign-tablets-found · Updated August 17, 2026 · FDA enforcement record: FDA #D-0532-2025

Cite this page

“Lupin Lisinopril/Hydrochlorothiazide Tablets Recall: Foreign Tablets Found.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32014-lupin-lisinopril-hydrochlorothiazide-tablets-recall-foreign-tablets-found. Based on FDA recall #D-0532-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0532-2025%22&limit=1).

Lupin Pharmaceuticals Inc. recalled 58,968 bottles of Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg due to a foreign tablet mix-up, the FDA said on June 20, 2025. The recall was initiated voluntarily by the firm.

How to tell if you have it

  • Lupin Pharmaceuticals
  • Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg
  • 100-count bottles
  • Rx only
  • NDC 68180-519-01
  • Lot #: QA01081
  • Exp. Date April 2027

The hazard

The product is being recalled because a complaint reported that a sealed bottle contained a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg instead of the expected lisinopril and hydrochlorothiazide tablets.

Context

GovInfoNow's records show Lupin Pharmaceuticals Inc. has 90 other recalls on record since Jan. 31, 2013. Other recent recalls of similar products include Lupin Clobetasol Cream Recall (Aug. 3, 2026), Lupin Glucagon Emergency Kit Recall (June 23, 2026), and Lupin prednisolone acetate ophthalmic suspension recall (June 4, 2026). Other recent recalls of similar products include Unichem Bisoprolol/Hydrochlorothiazide Tablets Recall (Jan. 21, 2026), Bionpharma Divalproex Tablets Recall (June 26, 2026), and Granules Pharmaceuticals Trazodone 50mg Recall (Jan. 26, 2026).

How to tell if you have this one

Check for 100-count bottles labeled 'Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg' with NDC 68180-519-01 and lot number QA01081. The product is for prescription use only.

  • Brand
    Lupin Pharmaceuticals
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product

    Look for the product name, NDC number, and lot number on the bottle to confirm if it's recalled.

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: “Product was distributed nationwide within the United States.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 33 days after the firm started it.

1. Firm started the recall: Jun 20, 202512. FDA classified it Class II: Jul 17, 202523. Published in FDA’s Enforcement Report: Jul 23, 202532025
  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-0532-2025 (June 20, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0532-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 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