Open official notice

Towa Pharmaceutical "Loxoprofen Na Tape 50mg ‘Towa’" and 3 other products - Recall

Official notice

15 Jul 2026

Last checked

27 Oct 2026

RecallScope risk estimate:MediumCAA Japan

An official CAA Japan notice concerns Towa Pharmaceutical "Loxoprofen Na Tape 50mg ‘Towa’" and 3 other products - Recall. Manufacturing and process controls were found to have been performed using methods differing from those in the approval document, and deficiencies in records were identified. Reason for recall: At the contract manufacturer for these products, manufacturing and process controls were found to have been performed using methods differing from those in the approval document, and deficiencies in records were identified. It was therefore determined that product quality could not be adequately assured, and a voluntary recall will be conducted. Specific potential health effects: Stability test results and test results for retained samples and other samples within their expiration dates have confirmed that product quality is unaffected. Consequently, safety and efficacy are unaffected, and serious health effects are not considered likely. No health effects related to this matter have been reported to date. Published 2026-07-15.

What to do now

All pharmaceutical wholesalers and other recipients supplied with the affected lots have been identified. They will be notified of the recall in writing, and the products will be recalled.

Recall number

2-12890

Official notice

2026-07-15

The hazard

Manufacturing and process controls were found to have been performed using methods differing from those in the approval document, and deficiencies in records were identified. Reason for recall: At the contract manufacturer for these products, manufacturing and process controls were found to have been performed using methods differing from those in the approval document, and deficiencies in records were identified. It was therefore determined that product quality could not be adequately assured, and a voluntary recall will be conducted. Specific potential health effects: Stability test results and test results for retained samples and other samples within their expiration dates have confirmed that product quality is unaffected. Consequently, safety and efficacy are unaffected, and serious health effects are not considered likely. No health effects related to this matter have been reported to date.

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.

Recall Numbers

2-12890

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Affected products

Product 1

ロキソプロフェンNaテープ50mg「トーワ」 ロキソプロフェンNaテープ100mg「トーワ」 ジクロフェナクナトリウムテープ15mg「トーワ」 ジクロフェナクナトリウムテープ30mg「トーワ」

Hazard

Manufacturing and process controls were found to have been performed using methods differing from those in the approval document, and deficiencies in records were identified. Reason for recall: At the contract manufacturer for these products, manufacturing and process controls were found to have been performed using methods differing from those in the approval document, and deficiencies in records were identified. It was therefore determined that product quality could not be adequately assured, and a voluntary recall will be conducted. Specific potential health effects: Stability test results and test results for retained samples and other samples within their expiration dates have confirmed that product quality is unaffected. Consequently, safety and efficacy are unaffected, and serious health effects are not considered likely. No health effects related to this matter have been reported to date.

Where it was sold

Retailer information is not currently available in RecallScope. Check the official notice for distribution details.

Location 1

JP · Japan

Affected area 1

JP · Japan

Company & contacts

Brand

東和薬品

Manufacturer

東和薬品株式会社

Phone

0120-108-932

Brand: 東和薬品. Contact: 東和薬品株式会社 学術部DIセンター. Phone 0120-108-932.

Source & status

Source

Tier

official

Category

HEALTH

Official classification

PMDA Class II — 回収

Recall details

Recall number

2-12890

Event id

CAA-00000035558

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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