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Nipro “Febuxostat Tablets 10mg ‘Nipro’” - Recall
Official notice
23 Jul 2026
Last checked
27 Oct 2026
An official CAA Japan notice concerns Nipro “Febuxostat Tablets 10mg ‘Nipro’” - Recall. An active pharmaceutical ingredient was used beyond the validity period specified in the approval document. Reason for recall: It was confirmed that an active pharmaceutical ingredient beyond the validity period specified in the approval document was used in some units of this medicine. We have therefore decided to voluntarily recall products from the affected lot. Specific potential health effects: The active pharmaceutical ingredient was confirmed to pass quality tests immediately before use in manufacturing, and the manufactured products also passed tests at shipment and tests of retained samples. We therefore consider that there is no effect on quality, safety or efficacy and no risk of serious adverse health effects. No adverse health effects related to this matter have been reported to date. Published 2026-07-23.
What to do now
We have identified all pharmaceutical wholesalers, medical institutions and other recipients supplied with the affected lot. We will notify the affected medical institutions and other recipients in writing and recall the products.
Units affected
8,522
Recall number
2-12904
Official notice
2026-07-23
The hazard
The hazard
An active pharmaceutical ingredient was used beyond the validity period specified in the approval document. Reason for recall: It was confirmed that an active pharmaceutical ingredient beyond the validity period specified in the approval document was used in some units of this medicine. We have therefore decided to voluntarily recall products from the affected lot. Specific potential health effects: The active pharmaceutical ingredient was confirmed to pass quality tests immediately before use in manufacturing, and the manufactured products also passed tests at shipment and tests of retained samples. We therefore consider that there is no effect on quality, safety or efficacy and no risk of serious adverse health effects. No adverse health effects related to this matter have been reported to date.
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Check the official notice for the affected products and next steps.
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Affected products
Product 1
Units affected
Hazard
Where it was sold
Where it was sold
Retailer information is not currently available in RecallScope. Check the official notice for distribution details.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand
Manufacturer
Phone
Brand: ニプロ. Contact: ニプロ株式会社 信頼性保証本部 医薬品質保証部. Phone 06-6310-6944.
Source & status
Source & status
Recall details
Recall details
Recall number
Event id
Units affected
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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