Recalls · Brand

MALLINCKRODT PHARMACEUTICALS recalls

Every recall we track for MALLINCKRODT PHARMACEUTICALS — 2 in all, all from 2019 — plus the complaints and injury reports the public filed about them.

2recalls

12complaints & reports

8injuries reported

Recalls per year, by danger level

2 recalls since 2017.

All FDA recall records for MALLINCKRODT PHARMACEUTICALS since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.

Recalls per year for MALLINCKRODT PHARMACEUTICALS, by danger level
Year	Lower risk	Total
2017	0	0
2018	0	0
2019	2	2
2020	0	0
2021	0	0
2022	0	0
2023	0	0
2024	0	0
2025	0	0
2026 (to date)	0	0

What to do if you have a recalled MALLINCKRODT PHARMACEUTICALS product

Match the NDC and lot number on your bottle or box to the recall.
Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first.
Report side effects to FDA MedWatch.

See this week’s new recalls.

All MALLINCKRODT PHARMACEUTICALS recalls

1 shown

Lower riskDrug
MALLINCKRODT PHARMACEUTICALS recalls Amitiza (lubiprostone) capsules, 8 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC
Mallinckrodt recalls Amitiza 8mcg capsules (60-count) due to labeling mix-up where 24mcg capsules were mistakenly included in 8mcg bottles. This affects prescription-only medication.
Mallinckrodt PharmaceuticalsMay 13, 2019

MALLINCKRODT PHARMACEUTICALS recall questions

How many recalls has MALLINCKRODT PHARMACEUTICALS had?

2 recalls from MALLINCKRODT PHARMACEUTICALS are on record with U.S. safety agencies, from 2019.

What is the most recent MALLINCKRODT PHARMACEUTICALS recall?

MALLINCKRODT PHARMACEUTICALS recalls Amitiza (lubiprostone) capsules, 8 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC, dated May 13, 2019. Every MALLINCKRODT PHARMACEUTICALS recall is listed on this page, newest first.

What should I do if I have a recalled MALLINCKRODT PHARMACEUTICALS product?

Match the NDC and lot number on your bottle or box to the recall. Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first. Report side effects to FDA MedWatch.

How do I get alerts for new MALLINCKRODT PHARMACEUTICALS recalls?

Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.