Takeda Recalls Amitiza Capsules Due to Elevated Impurity Levels
Takeda is recalling specific lots of Amitiza (lubiprostone) capsules because stability testing found elevated levels of a known impurity.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which indicates the product is not likely to cause adverse health consequences. The hazard is a quality control issue (impurity) rather than a direct safety threat like contamination or mislabeling.
Plain-English summary
Takeda Development Center Americas, Inc. is recalling 69,075 bottles of Amitiza (lubiprostone) 8 mcg capsules. The recall affects 60-count bottles with NDC 64764-080-60, Lot # 3098628-61, and an expiration date of 02/28/2021. The total quantity involved is 4,144,500 capsules.
The recall was initiated due to failed impurities and degradation specifications. Specifically, elevated levels of a known impurity were detected in 20-month stability sample testing. The active ingredient was manufactured in Japan and encapsulated in the United States.
The product was distributed to 32 distributors throughout the United States. Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product matches the recalled lot, it should be returned to the pharmacy or distributor for a refund or replacement.
The recalled product
- Product
- AMITIZA (LUBIPROSTONE)
- Brand
- AMITIZA
- Manufacturer
- Takeda Development Center Americas, Inc.
- Category
- Drug — Prescription Medication
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 3098628-61
- exp. date 02/28/2021
Distribution
Distribution scope not specified by the agency.
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