Quality & complianceOfficial

MHRA orders Class 3 recall of Aspire Pharma tropicamide eye drops over wrong expiry date

🇬🇧 MHRA alerts · Thu 05 Nov 2026

Three batches of Tropicamide 1% single-dose eye drops carry an expiry date of April 2027, but the correct date is 31 October 2026, the MHRA says.

The Medicines and Healthcare products Regulatory Agency has issued a Class 3 medicines recall, reference EL(26)A/47, for three batches of Aspire Pharma's Tropicamide 1% Eye Drops. The product is a solution in single-dose containers, in packs of 20 x 0.5ml (PL 35533/0198). The alert was published on 5 November 2026.

The affected batches are E941A, E941B and E941C. All are printed with an expiry date of 30/04/2027, which the MHRA identifies as incorrect. The correct expiry date for these batches should be 31/10/2026. First distribution dates were 29/10/2025 for E941A, 04/02/2026 for E941B and 20/02/2026 for E941C.

Healthcare professionals are told to stop supplying the batches immediately, quarantine remaining stock and return it to their supplier through the supplier's approved process. The notice is directed at dispensing GP practices and pharmacies, and NHS regional teams are asked to pass it on to community pharmacists and dispensing GPs.

For patients, the MHRA says no action is required. The recall is precautionary and is carried out at pharmacy and wholesaler level. Patients who hold these batches should keep using the drops and ask their prescriber for a replacement prescription. The agency says no reports of adverse incidents linked to the defect have been received so far. Suspected adverse reactions can be reported through the Yellow Card scheme.

Aspire Pharma has given contact details for medical information and stock-control queries in the alert. As general context, Class 3 is the lowest-risk category of drug recall in the MHRA system and is typically used for defects unlikely to cause harm to patients.

What it means for your team

  • Check stock for batches E941A, E941B and E941C and quarantine any found; the printed expiry of 30/04/2027 should not be relied on.
  • Use 31/10/2026 as the correct expiry date for these batches when assessing stock and any product still in the supply chain.
  • Return quarantined packs via the supplier's approved process and keep records of the action taken.
  • No adverse incidents have been reported, but PV teams should continue to handle any suspected reactions via Yellow Card.

Official source: MHRA alerts ↗

Article written by VigiEye from the official source (MHRA alerts). AI-assisted; check the source before acting.

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