FDA Drug recall D-0286-2019
AMITIZA (lubiprostone) capsules 8 mcg. 60-count bottle, Rx Only
- FDA Drug
- Class III
- terminated
- Published 2018-11-21
On 2018-11-21 the FDA classified a Class III recall of AMITIZA (lubiprostone) capsules 8 mcg. 60-count bottle, Rx Only by Takeda Development Center Americas, citing failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0286-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-11-06 |
| Published | 2018-11-21 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Takeda Development Center Americas |
| Distribution | US |
Product
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
Reason
Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.
Identifiers
| ndc | 64764-080-60 |
|---|---|
| ndc | 64764-080-40 |
| ndc | 64764-240-60 |
| ndc | 64764-240-10 |
| ndc | 64764-240-40 |
| code_info | Lot # 3098628-61, exp. date 02/28/2021 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0286-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.