Safety Recall: Nipro Febuxostat Tablets 10mg “Nipro” – Japan CAA

Published by Reclia Safety Desk | July 23, 2026

Recall Information Record

Case Number: 00000035591
Product: Febuxostat Tablets 10mg “Nipro”
Brand: Nipro
Hazards: Safety Risk
Source: Japan Consumer Affairs Agency (CAA)

WHAT HAPPENED

Nipro Corporation has initiated a voluntary recall of Febuxostat Tablets 10mg “Nipro” (product ID: 00000035591) after discovering that the active pharmaceutical ingredient used in the affected batches exceeded the approved shelf life as defined in the product’s marketing authorization. This violation of Good Manufacturing Practice (GMP) standards was identified during internal quality control checks and promptly reported to the Consumer Affairs Agency (CAA) of Japan.

The use of expired active ingredients may compromise the potency and stability of the medication, potentially reducing its therapeutic efficacy in managing hyperuricemia and gout. While no immediate safety incidents have been reported, the recall is being conducted as a precautionary measure to ensure patient safety and maintain regulatory compliance. The recall notice was published on the CAA’s official recall information site, referencing PMDA as the source of further technical details.

Consumers and healthcare providers are advised to take the following actions:

• Check the product name and packaging for “フェブキソスタット錠10mg「ニプロ」” and verify if the product is part of the recall.
• Discontinue use of any affected tablets and return them to the point of purchase or contact Nipro directly for replacement or refund.
• Consult with a physician or pharmacist for alternative treatment options if you are currently taking this medication.

AFFECTED BATCHES & TARGET SPECIFICS

– **Target Model / Type:** N/A
– **JAN Barcode:** N/A
– **Affected Serial / Lot Numbers:** N/A
– **Total Units Affected:** N/A

ADDITIONAL REGULATORY NOTES

Recall due to use of active pharmaceutical ingredient that exceeded the approved shelf life as specified in the marketing authorization. The recall was initiated on July 22, 2026. Reference information is provided by PMDA.

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