Class III
Terminated
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
- Recall Initiated
- November 6, 2018
- Posted
- November 21, 2018
- Recall Number
- D-0286-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 69,075 60-count bottles (4,144,500 capsules)
- Firm Location
- Deerfield, IL, United States
Reason for Recall
Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.
Distribution
Product was distributed to 32 distributors throughout the United States.
Lot / Code Info
Lot # 3098628-61, exp. date 02/28/2021
More recalls by Takeda Development Center Americas, Inc.
Other recent Class III Drug recalls
Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Via...
Slate Run Pharmaceuticals
· Mar 4, 2026
Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed by Unichem Pharmaceutica...
Unichem Pharmaceuticals Usa Inc.
· Feb 18, 2026
parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint. Net Wt 16.9 FL OZ (500 mL),...
Haleon Us Holdings Llc
· Feb 4, 2026
Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, Manufactured by: MSN Pharmaceutic...
Novadoz Pharmaceuticals Llc
· Feb 4, 2026
Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd.,...
Cipla Usa, Inc.
· Jan 28, 2026