US Drug Recall Register
Class II · Moderate risk Terminated Initiated Mar 15, 2021 (5 years ago)

Linzess (linaclotide) capsules 72 mcg/capsule 30 capsules Rx Only NDC 0456-1203-30…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

What was recalled

Linzess (linaclotide) capsules 72 mcg/capsule 30 capsules Rx Only NDC 0456-1203-30 Distributed by: Allergan USA, Inc. Irvine, CA 92612

Recalling firm
Cardinal Health Inc.
NDC code
0456-1203-30
Origin
OH, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0417-2021

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.