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 16, 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 product specifications, and that there were deficiencies in record-keeping.

This recall matters because the affected products may not meet the quality and safety standards required by regulatory approval. Patients using these tapes for pain relief could be exposed to unknown risks due to potential variations in drug content, release characteristics, or contamination. The Consumer Affairs Agency of Japan has listed this recall on its official information site under management number 00000035559, with reference data from the Pharmaceuticals and Medical Devices Agency (PMDA).

Users who have purchased any of the recalled products should take the following steps:

• Check the product name and packaging to confirm if it matches one of the four recalled items.
• Discontinue use immediately and consult your healthcare provider for alternative treatment options.
• Contact Sanwa Chemical Research Institute or the point of contact listed in the recall notice for instructions on returning the product and obtaining a refund or replacement.

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 product specifications, along with record-keeping deficiencies. Reference information from PMDA is provided. Management number: 00000035559.

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