Safety Recall: Nipro Pharma Loxoprofen Na Tape 50mg ‘NP’, Loxoprofen Na Tape 100mg ‘NP’, Felbinac Tape 35mg ‘NP’, Felbinac Tape 70mg ‘NP’, Diclofenac Sodium Tape 15mg ‘NP’, Diclofenac Sodium Tape 30mg ‘NP’ – Japan CAA

Published by Reclia Safety Desk | July 16, 2026

Recall Information Record

Case Number: 00000035557
Product: Loxoprofen Na Tape 50mg ‘NP’, Loxoprofen Na Tape 100mg ‘NP’, Felbinac Tape 35mg ‘NP’, Felbinac Tape 70mg ‘NP’, Diclofenac Sodium Tape 15mg ‘NP’, Diclofenac Sodium Tape 30mg ‘NP’
Brand: Nipro Pharma
Hazards: Safety Risk
Source: Japan Consumer Affairs Agency (CAA)

WHAT HAPPENED

Nipro Pharma has issued a recall for six topical analgesic tape products: Loxoprofen Na Tape 50mg ‘NP’, Loxoprofen Na Tape 100mg ‘NP’, Felbinac Tape 35mg ‘NP’, Felbinac Tape 70mg ‘NP’, Diclofenac Sodium Tape 15mg ‘NP’, and Diclofenac Sodium Tape 30mg ‘NP’. The recall was prompted by the discovery that manufacturing and process control were conducted in a manner inconsistent with the approved marketing authorization, and that related records were found to be incomplete or inadequate.

This situation is significant because deviations from approved manufacturing methods can affect the quality, safety, and efficacy of pharmaceutical products. Patients relying on these tapes for pain relief may be exposed to substandard medication, potentially leading to therapeutic failure or unexpected side effects. The recall underscores the importance of strict adherence to Good Manufacturing Practice (GMP) standards in pharmaceutical production.

If you have any of the affected products, please take the following steps:

• Check the product name and packaging to confirm if it matches one of the six recalled items.
• Discontinue use of the product immediately and consult your pharmacist or healthcare provider for a replacement or alternative treatment.
• Contact Nipro Pharma or the point of sale for instructions on returning the product and obtaining a refund or exchange.

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 due to manufacturing and process control deviations from approved specifications, along with record-keeping deficiencies. Contact and remedy details are not provided in the notice. The recall start date is July 14, 2026. Reference is made to PMDA (Pharmaceuticals and Medical Devices Agency).

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