Reported Jan 30, 2019 · Terminated

Ezetimibe and Simvastatin Tablets 10mg/80 mg, 1000-count bottles, Rx only, Manufactured by: Teva Pharmaceuticals Ind.…

Dr. Reddy's Laboratories, 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: Dr. Reddy's Laboratories, Inc. · 107 College Rd E · Princeton, NJ · 08540-6623

Is this the product you have?

    • Ezetimibe and Simvastatin Tablets 10mg/80 mg
    • 1000-count bottles
    • Rx only
  • Manufactured byTeva Pharmaceuticals Ind. Ltd. Jerusalem, 9777402, Israel
  • Distributed by
    • Dr. Reddy's Laboratories Inc. Princeton
    • NJ 08540 USA
    • NDC 43598-586-10
Lot codes and dates
    • Lot #: 43E021 and 43E023
    • Exp. 01/2020
Amount recalled
118 bottles

Where it was sold

  • Nationwide

Why it was recalled

Presence of Foreign Substance: Product complaint of black speckles observed on tablets.

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 Mar 3, 2020 · Data as of Sep 19, 6:37 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.