CLASS III Drug recall · Reported 21 Nov 2018 · FDA Enforcement Report
Amitiza (lubiprostone) capsules 8 mcg recalled
Takeda Development Center Americas is recalling Amitiza (lubiprostone) capsules 8 mcg, distributed nationwide in the US. The recall was initiated on 6 Nov 2018 and the FDA has classified it as Class III.
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-0286-2019
- FDA event ID
- 81518
- Recalling firm
- Takeda Development Center Americas, Deerfield, IL
- Brand
- Amitiza
- Manufacturer
- Takeda Pharmaceuticals America, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 6 Nov 2018
- FDA classified
- 28 Nov 2018
- Reported
- 21 Nov 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 6 Nov 2018 | Recall initiated by company | |
| 21 Nov 2018 | Published in enforcement report | +15 days |
| 28 Nov 2018 | Classified by FDA | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
AMITIZA (lubiprostone) capsules 8 mcg. 60-count bottle, Rx Only. Marketed by: Sucampo Pharma Americas, LLC, Rockville MD 20850 and Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015. Active Ingredient made in Japan, encapsulated in the United States. NDC 64764-080-60
Where it was distributed
Product was distributed to 32 distributors throughout the United States.
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.
Which lots are affected?
Lot # 3098628-61, exp. date 02/28/2021
Where was it sold?
Product was distributed to 32 distributors throughout the United States.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
More recalls from Takeda Development Center Americas
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Actoplus met XR (pioglitazone and metformin HCl recalled | Takeda Development Center Americas | Other | 9 states |
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 II | Amitiza (lubiprostone) capsules, 8 mcg recalledAmitiza | Mallinckrodt Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Lubiprostone Capsule, 24 mcg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |