Precautionary recall announced for specific batch of Zaditen eye drops in the UK

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A Class 2 medicines recall of Zaditen 0.25 mg/mL, eye drops, solution, has been issued in the United Kingdom after Laboratoires Théa notified the Medicines and Healthcare products Regulatory Agency (MHRA) of an event during manufacturing that may increase the risk of microbial contamination in the product.¹ This recall is precautionary, and there are currently no adverse events reported.

Batch number 4V64 of Zaditen 0.25 mg/mL eye drops solution was first distributed on January 27, 2025, and has an expiration date of September 30, 2026.

Due to the recall, the MHRA has advised health care professionals to stop supplying the batch immediately and quarantine all stock and return it to the supplier from which it was received. A confirmed 11,360 packs of the affected batch have been distributed, according to Thea Pharmaceuticals. At the time of this article, no reported adverse events or product quality complaints have been received.

For patients, no further action is required, “as this is a pharmacy- and wholesaler-level recall related to a specific batch of Zaditen 0.25 mg/mL eye drop solution,” the MHRA said in a press release. Should any suspected adverse reactions arise, they can be reported via the MHRA Yellow Card scheme.¹

For stock control inquiries¹:

• For pharmacies supplied by a wholesaler, returns should be made via the wholesaler.
• For wholesalers, contact Mawdsleys PreWholesaler (MPS) customer services via email: customer.services@mpwpharma.co.uk.
• For health care establishments, arrange local destruction and make a claim through MPS via email: customer.services@mpwpharma.co.uk.

For more information, email thea-pharma@medinformation.co.uk.

Reference

1. Class 2 medicines recall: Zaditen 0.25 mg/ml, eye drops, solution, Laboratoires Théa EL(25)A/34. Gov.UK. July 7, 2025. Accessed July 8, 2025. https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-zaditen-0-dot-25-mg-slash-ml-eye-drops-solution-laboratoires-thea-el-25-a-slash-34