Lubiprostone recalls

The FDA has published 4 recalls involving Lubiprostone since 2014. The latest was reported on 29 May 2019. Most were for packaging defects. Mallinckrodt Pharmaceuticals has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls4since 2014

Last 12 months0reported

Class I00% of total

Ongoing0latest 29 May 2019

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 3 75%Class III 1 25%

Why lubiprostone is recalled

Companies

By year

2019250%
2018125%
2014125%

All lubiprostone recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
29 May 2019Drug	CLASS II	Amitiza (lubiprostone) capsules, 24 mcg recalledAmitiza	Mallinckrodt Pharmaceuticals	Packaging Defects	Nationwide
29 May 2019Drug	CLASS II	Amitiza (lubiprostone) capsules, 8 mcg recalledAmitiza	Mallinckrodt Pharmaceuticals	Packaging Defects	Nationwide
21 Nov 2018Drug	CLASS III	Amitiza (lubiprostone) capsules 8 mcg recalledAmitiza	Takeda Development Center Americas	Potency & Assay	Nationwide
22 Jan 2014Drug	CLASS II	Lubiprostone Capsule, 24 mcg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states

Should you stop taking Lubiprostone?

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.