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Santen “Pranoprofen Ophthalmic Solution 0.1% ‘Santen’” - Recall
Official notice
19 Oct 2026
Last checked
27 Oct 2026
An official CAA Japan notice concerns Santen “Pranoprofen Ophthalmic Solution 0.1% ‘Santen’” - Recall. The content of the active ingredient pranoprofen was found to have decreased and to fall below the approved specification within the shelf life. Reason for recall: Stability monitoring revealed a decrease in the content of the active ingredient pranoprofen in some lots of the affected product, and it was determined that the content would fall below the approved specification within the shelf life. An investigation confirmed that a particular raw material with a high iron ion content contributed to the degradation of pranoprofen in the ophthalmic solution. Therefore, lots manufactured using raw material with a high iron ion content whose pranoprofen content may fall below the approved specification are being voluntarily recalled. Specific potential health effects: Although the pranoprofen content in the recalled lots has decreased, the decrease is small, and the iron ion content is also at trace levels. Consequently, the company considers that there is no possibility of serious adverse health effects arising from this issue. To date, no reports of adverse health effects or lack of efficacy considered attributable to this issue have been received. Published 2026-10-19.
What to do now
The company has identified all pharmaceutical wholesalers and other recipients supplied with the affected lot numbers and will notify them of the recall in writing and collect the products.
Recall number
2-12999
Official notice
2026-10-19
The hazard
The hazard
The content of the active ingredient pranoprofen was found to have decreased and to fall below the approved specification within the shelf life. Reason for recall: Stability monitoring revealed a decrease in the content of the active ingredient pranoprofen in some lots of the affected product, and it was determined that the content would fall below the approved specification within the shelf life. An investigation confirmed that a particular raw material with a high iron ion content contributed to the degradation of pranoprofen in the ophthalmic solution. Therefore, lots manufactured using raw material with a high iron ion content whose pranoprofen content may fall below the approved specification are being voluntarily recalled. Specific potential health effects: Although the pranoprofen content in the recalled lots has decreased, the decrease is small, and the iron ion content is also at trace levels. Consequently, the company considers that there is no possibility of serious adverse health effects arising from this issue. To date, no reports of adverse health effects or lack of efficacy considered attributable to this issue have been received.
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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Where it was sold
Where it was sold
Retailer information is not currently available in RecallScope. Check the official notice for distribution details.
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Affected area 1
Company & contacts
Company & contacts
Brand
Manufacturer
Phone
Brand: 参天製薬. Contact: 参天製薬株式会社 コールセンター. Phone 06-7664-8621.
Source & status
Source & status
Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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