Reported Jul 23, 2025 · Ongoing

Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only, Mfg for: Lupin Pharmaceuticals,…

Lupin Pharmaceuticals Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Lupin Pharmaceuticals Inc. · 5801 Pelican Bay Blvd · Naples, FL · 34108-2755

Is this the product you have?

  • Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only
  • Mfg forLupin Pharmaceuticals, Inc. Baltimore, MD 21202
  • Manufactured by
    • Lupin Limited Nagpur-441 108
    • INDIA
    • NDC 68180-519-01
Lot codes and dates
    • Lot #: QA01081
    • Exp. Date April 2027
Amount recalled
58,968 bottles

Where it was sold

  • Nationwide

Why it was recalled

Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 3:32 PM UTC

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