AMITIZA — Class III drug recall D-0286-2019
Terminated recall by Takeda Development Center Americas, Inc., reported 2018-11-21, distributed nationwide. Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sam
| Recall number | D-0286-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Takeda Development Center Americas, Inc., Deerfield, IL, United States |
| Recall initiated | 2018-11-06 |
| Classified | 2018-11-28 |
| Reported by FDA | 2018-11-21 |
| Terminated | 2019-06-20 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 64764-0080, 64764-0080-40, 64764-0080-60, 64764-0240, 64764-0240-10, 64764-0240-40, 64764-0240-60 |
| Lot numbers | 3098628-61 |
| Expiration dates | 2021-02-28 |
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 for recall
Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0286-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.