A Class II recall of Linzess (linaclotide) capsules, 72 mcg per capsule, was initiated on March 15, 2021. The recall, identified as D-0417-2021, was carried out by Cardinal Health Inc.
The reason cited was a CGMP deviation involving intermittent exposure to a temperature excursion during storage. The affected product was Linzess (linaclotide) capsules, 72 mcg per capsule, in 30 capsule packages, NDC 0456-1203-30, distributed by Allergan USA, Inc. of Irvine, California.
The FDA classified this action as Class II. The recall status is listed as terminated. This information comes from the FDA recalls database and reflects the facts of the enforcement record as reported.
The recall record does not state that the affected product caused harm or that patients experienced adverse effects. It documents a manufacturing and storage deviation identified under current good manufacturing practice requirements.
Readers seeking more background on linaclotide, including its approved uses and regulatory history, can consult the compound overview for additional context.