Reported Nov 25, 2020 · Terminated

Aripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000 count bottle, NDC 60505-2675-8; b) 30 count bottle, NDC…

Apotex Corp.

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: Apotex Corp. · 2400 N Commerce Pkwy Ste 400 · Weston, FL · 33326-3253

Is this the product you have?

    • Aripiprazole Tablets
    • USP 15 mg tablets
    • packaged in a) 1000 count bottle
    • NDC 60505-2675-8
    • b) 30 count bottle
    • NDC 60505-2675-3
    • Rx Only
  • Manufactured byApotex Inc. Toronto
  • Ontario Canada M9L 1T9 Manufactured forApotex Corp. Weston, Florida 33326
Lot codes and dates
    • a) PZ6716 Exp. 02/2021
    • b) PZ6715 Exp. 02/2021
Amount recalled
a)552 bottles; b) 3192 bottles

Where it was sold

  • Nationwide

Why it was recalled

Failed Dissolution Specifications: Out of specification for dissolution.

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 Aug 11, 2021 · Data as of Sep 19, 5:54 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.