Reported Jun 2, 2021 · Terminated

Vraylar (cariprazine) capsules in all pack sizes, styles and strengths Rx only Distributed by: Actavis Pharma, Inc.…

Cardinal Health 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: Cardinal Health Inc. · 7000 Cardinal Pl · Dublin, OH · 43017-1091

Is this the product you have?

  • Vraylar (cariprazine) capsules in all pack sizes, styles
  • and strengths Rx only Distributed byActavis Pharma, Inc. Parsippany, NJ 07054
Lot codes and dates
  • W04494
Amount recalled
759 bottles

This recall covers 198 products

The agency filed one notice per product. You are reading one of them; the other 197 are below.

185 more are in the archive.

Where it was sold

Why it was recalled

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

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 Jun 17, 2024 · Data as of Sep 19, 6:38 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.