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Amitiza recalls

Amitiza products have been recalled 3 times, most recently on 29 May 2019. The recalling company is usually Mallinckrodt Pharmaceuticals. The most common reason is packaging defects.

Total recalls3since 2018

Last 12 months0reported

Class I00% of total

Ongoing0latest 29 May 2019

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 2 67%Class III 1 33%

Why amitiza is recalled

Packaging Defects267%
Potency & Assay133%

Companies

By year

2019267%
2018133%

All amitiza recalls, newest first

3 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

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.