Reported Nov 6, 2019 · Terminated

Atorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario…

Apotex 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: Apotex Inc. · 150 Signet Drive · North York · N/A

Is this the product you have?

    • Atorvastatin Calcium Tablets
    • USP 40 mg*
    • 1
    • 000 count bottles
    • Rx Only
  • Manufactured byApotex Inc. Toronto
  • Ontario Canada M9L 1T9 Manufactured forApotex Corp. Weston, Florida 33326 NDC 60505-2580-8
Lot codes and dates
  • LotRC5439 Exp. 03/2022
Amount recalled
1968 bottles

Where it was sold

Why it was recalled

Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40 mg.

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 Feb 19, 2026 · Data as of Sep 19, 5:01 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.