Reported Apr 17, 2019 · Terminated

Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablet bottle, Rx only, Manufactured for: Lupin Pharmaceuticals,…

Lupin Pharmaceuticals Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

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?

  • Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablet bottle, Rx only
  • Manufactured forLupin Pharmaceuticals, Inc., Baltimore, MD
  • Manufactured byLupin Limited, Goa, INDIA -- NDC 68180-198-06
Lot codes and dates
    • G705843 Exp. date April
    • 2019 G707763 Exp. date August
    • 2019 G800434 Exp. date November
    • 2019
Amount recalled
12,504 bottles

Why it was recalled

Failed Impurities/Degradation Specifications; 18 month long term stability study.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Notice updated Jul 1, 2020 · Data as of Sep 19, 8:02 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.