Precautionary class 2 medicines recall of Zaditen 0.25 mg/ml, eye drops, solution, issued

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A class 2 medicines recall of Zaditen 0.25 mg/ml, eye drops, solution, has been issued 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 January 27, 2025, and has an expiration date of September 30, 2026.

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

For patients, the MHRA said 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 drops, solution,” according to a press release. Should any suspected adverse reactions arise, they can be reported via the MHRA Yellow Card scheme.¹

For stock control enquiries:¹

• For pharmacies supplied by a wholesaler, returns should be made via the wholesaler.
• For wholesalers, contact Mawdsleys PreWholesaler (MPS) customer services via email: [email protected].
• For healthcare establishments, arrange local destruction and make a claim through MPS via email: [email protected].

For more information of medical information, call 0345 521 1290 (option 3) or email [email protected].

Reference:

1. Class 2 Medicines Recall: Zaditen 0.25 mg/ml, eye drops, solution, Laboratoires Théa EL(25)A/34. GOV.UK. Published 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

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