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Sawai Pharmaceutical “Betamethasone Tablets 0.5mg ‘Sawai’” - Recall
Official notice
23 Apr 2026
Last checked
27 Oct 2026
An official CAA Japan notice concerns Sawai Pharmaceutical “Betamethasone Tablets 0.5mg ‘Sawai’” - Recall. Dissolution does not meet the approved specifications. Reason for recall: Stability monitoring of Betamethasone Tablets 0.5mg “Sawai”, lot numbers 623701 (at year 2) and 622701 (at year 3), yielded dissolution results that did not meet the approved specifications for either lot. In response, dissolution was checked using retained samples from lots of Betamethasone Tablets 0.5mg “Sawai” within their shelf life, and some lots yielded results that did not meet the approved specifications. Therefore, it was decided to recall lots whose dissolution may fail to meet the specifications within their shelf life. Specific potential health effects: Delayed dissolution may delay absorption and the onset of effects. However, because the assay values meet the approved specifications, serious health effects are not considered likely. No reports of health effects or lack of efficacy related to this matter have been received to date. Published 2026-04-23.
What to do now
We will provide written information to all businesses supplied with the product and appropriately conduct a voluntary recall.
Recall number
2-12772
Official notice
2026-04-23
The hazard
The hazard
Dissolution does not meet the approved specifications. Reason for recall: Stability monitoring of Betamethasone Tablets 0.5mg “Sawai”, lot numbers 623701 (at year 2) and 622701 (at year 3), yielded dissolution results that did not meet the approved specifications for either lot. In response, dissolution was checked using retained samples from lots of Betamethasone Tablets 0.5mg “Sawai” within their shelf life, and some lots yielded results that did not meet the approved specifications. Therefore, it was decided to recall lots whose dissolution may fail to meet the specifications within their shelf life. Specific potential health effects: Delayed dissolution may delay absorption and the onset of effects. However, because the assay values meet the approved specifications, serious health effects are not considered likely. No reports of health effects or lack of efficacy related to this matter have been received to date.
How to check if you're affected
How to check if you're affected
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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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Company & contacts
Company & contacts
Brand
Manufacturer
Phone
Brand: 沢井製薬. Contact: 沢井製薬株式会社 信頼性保証本部. Phone 0120-381-223.
Source & status
Source & status
Recall details
Recall details
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Documents, notices & source
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