Reported Aug 21, 2019 · Terminated

Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 100 tablet bottle, Rx only, Manufactured by for: Lupin…

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. · 111 S Calvert St Fl 21ST · Baltimore, MD · 21202-6174

Is this the product you have?

  • Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 100 tablet bottle, Rx only
  • Manufactured by forLupin Pharmaceuticals, Inc., Baltimore, MD
  • Manufactured byLupin Limited, Pithampur, INDIA NDC 68180-518-01
Lot codes and dates
    • Batch# H900575
    • exp. date 01/2022
Amount recalled
39,216 bottles

Why it was recalled

Presence of Foreign Substance; Product complaints received related to brownish/blackish stains on the tablets and brownish/blackish powder observed inside the bottles.

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

Notice updated Sep 14, 2020 · Data as of Sep 19, 7:23 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.