Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
AMITIZA (lubiprostone) capsules 8 mcg. 60-count bottle Recalled by Takeda Development Center Americas, Inc. Due to Failed Impurities/Degradation Specifications:Elevated levels of a known impurity...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Takeda Development Center Americas, Inc. directly.
Affected Products
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
Quantity: 69,075 60-count bottles (4,144,500 capsules)
Why Was This Recalled?
Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.
Where Was This Sold?
Product was distributed to 32 distributors throughout the United States.
About Takeda Development Center Americas, Inc.
Takeda Development Center Americas, Inc. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report