MHRA announces Mynzepli batch recall over syringe finger-grip size variation

What Changed

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Class 2 medicines recall notice for two batches of Advanz Pharma Limited’s Mynzepli 40 mg/mL solution for injection in pre-filled syringe. The precautionary recall follows a small variation in finger-grip size that could affect administration and potentially pose a risk to patient safety.

The affected batches are 2325742 and 2325726. Mynzepli contains aflibercept and has marketing authorisation number PL 56734/0022.

Who Is Affected

The recall operates at pharmacy and wholesaler level, affecting organisations holding or supplying the specified batches and relevant healthcare professionals. The medicine is administered only by a qualified healthcare professional experienced in intravitreal injections.

Patients do not need to take further action in relation to the recall. Those experiencing adverse reactions or with questions about the medicine should seek medical attention. Suspected adverse reactions should also be reported through the MHRA Yellow Card scheme.

Regulatory and Technical Implications

Although classified as a medicines recall, the issue concerns a component of the pre-filled syringe used during administration. The finger grip, or flange, provides a surface that helps the user hold the syringe securely while applying pressure to the plunger rod.

The MHRA identifies the size variation as a potential administration and patient-safety concern. The recall covers the two specified batches; Advanz Pharma has confirmed that other, unaffected batches remain available for distribution.

Manufacturer Actions

Advanz Pharma is recalling the affected batches as a precaution. The MHRA instructs healthcare professionals to stop supplying them immediately, quarantine all remaining stock and return it to their supplier using the supplier’s approved process.

Recipients are asked to bring the notice to relevant contacts’ attention. NHS regional teams are also asked to forward it to community pharmacists and dispensing general practitioners.

Confirmed Dates

The MHRA notice was published and issued on 29 October 2026. Batch 2325742 expires in June 2027 and was first distributed on 2 January 2026. Batch 2325726 expires in May 2027 and was first distributed on 10 October 2025. Both entries list a pack size of 1.

Official Source

MHRA Class 2 medicines recall notice EL(26)A/44, with Defective Medicines Report Centre reference DMRC - 41252013. Product enquiries can be directed to Advanz Pharma at medicalinformation@advanzpharma.com or +44 (0) 208 588 9131.

Https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-advanz-pharma-limited-mynzepli-40-mg-slash-ml-solution-for-injection-in-pre-filled-syringe-el-26-a-slash-44