Takeda Development Center Americas, Inc. is recalling 69,075 bottles of AMITIZA (lubiprostone) 8 mcg capsules, which are used to treat certain types of chronic constipation. This recall was initiated after routine stability testing at the 20-month mark revealed elevated levels of a known impurity that exceeded approved specifications. Approximately 4.1 million individual capsules are included in this recall, which affects 60-count bottles distributed to 32 distributors nationwide. Consumers should verify if they have the affected lot to ensure they are using medication that meets all safety and quality standards.
The presence of elevated impurities or degradation products means the medication no longer meets the required quality standards, which can potentially impact the drug's effectiveness or safety profile over time. While the risk level is currently categorized as low, using a product that has failed its stability specifications is not recommended.
Healthcare provider consultation and pharmacy refund
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Sources: FDA iRES · Raw API Response
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