Linaclotide recalls
The FDA has published 1 recall involving Linaclotide since 2021. The latest was reported on 2 Jun 2021. Most were for manufacturing (cgmp) deviations. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.
Total recalls1since 2021
Last 12 months0reported
Class I00% of total
Ongoing0latest 2 Jun 2021
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 1 100%Class III 0 0%
Why linaclotide is recalled
Companies
By year
All linaclotide recalls, newest first
1 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Linzess (linaclotide) capsules 72 mcg/capsule recalledLinzess | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
Should you stop taking Linaclotide?
Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.