Class 4 Medicines Defect Notification: Dulcolax Adult 5 Mg Gastro-resistant Tablets, Opella Healthcare Uk, El(25)a/26
Dulcolax Adult 5mg Tablets Recall Summary Opella Healthcare UK is recalling Dulcolax Adult 5mg Gastro-resistant Tablets (20-count boxes) because the package labeling incorrectly states the product is for use in ages 12 and older, when it is only intended for adults 18 and over. This labeling error affects packages distributed in the United Kingdom.
- Recalling firm
- Dulcolax Adult 5 mg Gastro-resistant Tablets
- Reason
- Opella Healthcare UK LTD has informed the MHRA that there is an error on the artwork for the outer carton of Dulcolax Adult 5mg GR Tablets (packsize 20 count). The dose instruction incorrectly states for use in 12 years and older. These general sale packs are intended for use only in adult patients (18 years and over).
- Classification
- Class III
- Category
- drug recall
- Country
- United Kingdom
- Agency
- UK Medicines and Healthcare products Regulatory Agency
- Recall date
- 2025-06-10
- Status
- Ongoing
- Distribution
- United Kingdom
Official recall notice from UK Medicines and Healthcare products Regulatory Agency
Recall details on Nibble Recalls: https://trynibble.app/recalls/faf5927f-dfe0-4011-b82c-f0243a24d87e