Reported Jun 2, 2021 · Terminated

Orilissa elagolix tablets 150 mg per tablet equivalent to 155.2 mg elagolix sodium, 28 Tablets For 28 Days Rx only NDC…

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?

  • Orilissa elagolix tablets 150 mg per tablet equivalent to 155.2 mg elagolix sodium, 28 Tablets For 28 Days Rx only NDC 0074-0038-28 Each carton contains 28 tablets in 4 weekly blister pack, Each weekly blister pack contains 7 tablets of elagolix 150 mg AbbVie Inc. North Chicago, IL 60064
Lot codes and dates
  • 1120778
Amount recalled
210 cartons

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, 7:22 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.