Pharmaceutical companyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Mallinckrodt plcLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Mallinckrodt Pharmaceuticals with 2 drug recalls. The most recent is a drug recall dated May 13, 2019: Amitiza (lubiprostone) capsules, 8 mcg, 60-count bottle, Rx only, Manufactured by: Sucam….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| May 13, 2019 | Amitiza (lubiprostone) capsules, 8 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC 64764-080-60Class II · Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were found in a 8 mcg trade 60 | Drug recalls |
| May 13, 2019 | Amitiza (lubiprostone) capsules, 24 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC 64764-240-60Class II · Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were found in a 8 mcg trade 60 | Drug recalls |
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