Takeda AMITIZA capsules 8 mcg recall: Impurity risk in stability testing
Takeda recalls AMITIZA (lubiprostone) 8 mcg capsules due to elevated impurities in stability testing. This may affect safety for patients using prescription medication.
Lower-risk recall
Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.
Contact the company
What happened, in plain English
Takeda is recalling AMITIZA (lubiprostone) capsules 8 mcg 60-count bottles because stability testing showed higher levels of a known impurity. This could pose a safety risk for patients using the medication. Read more at govinfonow.com/recall/39440-takeda-amitiza-capsules-8-mcg-recall-impurity-risk-in-stability.
Source Summary by GovInfoNow · govinfonow.com/recall/39440-takeda-amitiza-capsules-8-mcg-recall-impurity-risk-in-stability · Updated October 5, 2026 · FDA enforcement record: FDA #D-0286-2019
Cite this page
“Takeda AMITIZA capsules 8 mcg recall: Impurity risk in stability testing.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39440-takeda-amitiza-capsules-8-mcg-recall-impurity-risk-in-stability. Based on FDA recall #D-0286-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0286-2019%22&limit=1).
Why it’s dangerous
The recall is based on stability testing showing elevated levels of a known impurity in the medication. This impurity could potentially affect the medication's safety, though the exact risk level is not specified in the recall notice.
Who’s affected
Patients prescribed AMITIZA (lubiprostone) capsules 8 mcg 60-count bottles by a doctor. Those with specific medical conditions requiring this medication are most at risk.
How to tell if you have this one
Check for AMITIZA (lubiprostone) capsules 8 mcg 60-count bottles with NDC 64764-080-60 and lot number 3098628-61, expiring February 28, 2021.
- Brand
Takeda- Category
Drug
What to do — step by step
Check Medication Details
Verify the product's NDC code (64764-080-60) and lot number (3098628-61) to confirm if it is recalled.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Product was distributed to 32 distributors throughout the United States.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 7 months after the firm started it.
- Firm started the recall
- Published in FDA’s Enforcement Report
- FDA classified it Class III
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0286-2019 (November 6, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0286-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.