CLASS II Drug recall · Reported 29 May 2019 · FDA Enforcement Report
Amitiza (lubiprostone) capsules, 8 mcg recalled
Mallinckrodt Pharmaceuticals is recalling Amitiza (lubiprostone) capsules, 8 mcg, distributed nationwide in the US. The recall was initiated on 13 May 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1294-2019
- FDA event ID
- 82830
- Recalling firm
- Mallinckrodt Pharmaceuticals, Bedminster, NJ
- Brand
- Amitiza
- Manufacturer
- Takeda Pharmaceuticals America, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 May 2019
- FDA classified
- 23 May 2019
- Reported
- 29 May 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 13 May 2019 | Recall initiated by company | |
| 23 May 2019 | Classified by FDA | +10 days |
| 29 May 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were found in a 8 mcg trade 60 ct. bottle. Amitiza 24 mcg capsules are being recalled because a sealed 60 ct. bottle contained only 8 mcg capsules, this incident is being considered as a labeling mix-up issue.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Amitiza (lubiprostone) capsules, 8 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC 64764-080-60
Where it was distributed
US Nationwide
Questions about this recall
Why was it recalled?
Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were found in a 8 mcg trade 60 ct. bottle. Amitiza 24 mcg capsules are being recalled because a sealed 60 ct. bottle contained only 8 mcg capsules, this incident is being considered as a labeling mix-up issue.
Which lots are affected?
Lot #: 3229691-61, Exp 01/2022
Where was it sold?
US Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 82830| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Amitiza (lubiprostone) capsules, 24 mcg recalledAmitiza | Mallinckrodt Pharmaceuticals | Packaging Defects | Nationwide |
More recalls from Mallinckrodt Pharmaceuticals
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Amitiza (lubiprostone) capsules, 24 mcg recalledAmitiza | Mallinckrodt Pharmaceuticals | Packaging Defects | Nationwide |
Other Lubiprostone recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Amitiza (lubiprostone) capsules, 24 mcg recalledAmitiza | Mallinckrodt Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS III | Amitiza (lubiprostone) capsules 8 mcg recalledAmitiza | Takeda Development Center Americas | Potency & Assay | Nationwide |
| Drug | CLASS II | Lubiprostone Capsule, 24 mcg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |