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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81518

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 06, 2018
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Takeda Development Center Americas, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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

D-0286-2019
Recall number
D-0286-2019
Initiated
November 06, 2018
Classification
Class III
Status
Terminated
Quantity
69,075 60-count bottles (4,144,500 capsules)

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Impurities/Degradation Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.

Code information

Lot # 3098628-61, exp. date 02/28/2021

Distribution pattern

Product was distributed to 32 distributors throughout the United States.