Safety Recall: Sanwa Chemical Research Institute Diclofenac Sodium Tape 15mg ‘Sanwa’, Diclofenac Sodium Tape 30mg ‘Sanwa’, Loxoprofen Na Tape 50mg ‘Sanwa’, Loxoprofen Na Tape 100mg ‘Sanwa’ – Japan CAA

Published by Reclia Safety Desk | July 20, 2026

Recall Information Record

Case Number: 00000035559
Product: Diclofenac Sodium Tape 15mg ‘Sanwa’, Diclofenac Sodium Tape 30mg ‘Sanwa’, Loxoprofen Na Tape 50mg ‘Sanwa’, Loxoprofen Na Tape 100mg ‘Sanwa’
Brand: Sanwa Chemical Research Institute
Hazards: Safety Risk
Source: Japan Consumer Affairs Agency (CAA)

WHAT HAPPENED

Sanwa Chemical Research Institute has issued a voluntary recall for four topical analgesic tape products: Diclofenac Sodium Tape 15mg ‘Sanwa’, Diclofenac Sodium Tape 30mg ‘Sanwa’, Loxoprofen Na Tape 50mg ‘Sanwa’, and Loxoprofen Na Tape 100mg ‘Sanwa’. The recall was prompted by findings that manufacturing and process management were carried out in a manner deviating from the approved specifications, and that record-keeping was found to be inadequate.

These products are widely used for pain relief in conditions such as arthritis and muscle aches. The deviation from approved manufacturing methods and incomplete records raise concerns about potential inconsistencies in product quality, efficacy, and safety. Although no immediate adverse events have been reported, the recall is a precautionary measure to ensure patient safety and regulatory compliance.

Consumers who have purchased these products are advised to take the following steps:

• Check the product name on the package to confirm if it matches any of the recalled items.
• Discontinue use immediately and return the product to the place of purchase or contact Sanwa Chemical Research Institute for further instructions.
• For any health concerns or questions, consult a healthcare professional or pharmacist.

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 initiated on 2026-07-14 due to manufacturing and process management conducted in a manner inconsistent with the approved content, along with record-keeping deficiencies. Reference source: PMDA. Management number: 00000035559.

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