MHRA orders precautionary recall of Mynzepli aflibercept syringes after device variation flagged
The MHRA has classified the action as a Class 2 medicines recall for specified batches of Mynzepli 40 mg/mL solution for injection in pre-filled syringe, a product containing aflibercept and used for intravitreal administration. The recall is precautionary, but the concern is clinically meaningful: a small variation in the size of the finger grip could alter how the syringe is handled during injection and create a risk to patient safety.
In a device-dependent procedure such as intravitreal injection, small changes in syringe ergonomics can matter. The finger grip, or flange, is not cosmetic packaging; it provides the surface that allows the clinician to stabilize the pre-filled syringe while applying pressure to the plunger rod. If that platform is inconsistent, the operator’s control during administration can be affected at exactly the moment precision is most important.
Which batches are affected and what product is involved
The recall applies to two specified batches of Mynzepli 40 mg/mL solution for injection in pre-filled syringe. The affected batches are 2325742, with an expiry date of June 2027 and first distributed on 02/01/2026, and 2325726, with an expiry date of May 2027 and first distributed on 10/10/2025. The product license number is PL: 56734/0022, and the listed active ingredient is aflibercept.
Aflibercept is administered by qualified healthcare professionals experienced in intravitreal injection technique. In that setting, safety depends not only on the pharmacology of the anti-VEGF agent but also on the integrity and handling characteristics of the delivery system. A syringe that feels different in the hand can introduce avoidable uncertainty during an otherwise routine procedure.
Why a finger grip variation can affect intravitreal administration
Intravitreal injection is a high-precision ophthalmic intervention. The clinician must maintain steady control of the syringe, advance the plunger smoothly, and deliver the dose in a controlled manner. The flange helps anchor the syringe between the fingers, supporting that fine motor control. A small manufacturing variation in flange size could interfere with that grip, making administration less secure and potentially increasing the risk of a procedural error.
The regulatory response reflects the practical reality of device-assisted drug delivery in eye care. Even when the active ingredient is unchanged, the physical interface between clinician and product can alter how safely the dose is delivered. For injectable therapies that enter a narrow anatomic compartment, stable handling is part of the treatment itself.
Instructions for pharmacies, wholesalers, and dispensing practices
Healthcare professionals are instructed to stop supplying the affected batches immediately. Remaining stock should be quarantined and returned to the supplier through the supplier’s approved process. The notice also states that other unaffected batches of Mynzepli 40 mg/mL solution for injection in pre-filled syringe are currently available for distribution.
The recall is directed at pharmacy and wholesaler level, which means patients do not need to take action themselves. That limits the operational burden on the public, but it places the responsibility squarely on dispensing systems to intercept stock before it reaches the clinic or treatment site. In practice, that means inventory review, product segregation, and removal of the affected lots from circulation without delay.
Patient impact and reporting obligations
Patients are not expected to do anything as a result of this recall. The product is only administered by a qualified healthcare professional experienced in intravitreal injections, so the immediate control point sits with the dispensing chain and the clinical service rather than the patient. Anyone who experiences an adverse reaction or has questions about the medicine should seek medical attention.
Suspected adverse reactions should also be reported through the MHRA Yellow Card scheme. For a product recall of this kind, adverse-event reporting remains important because real-world experience can help distinguish a packaging or device issue from any downstream clinical consequence. Even precautionary recalls deserve that surveillance, especially when they involve a sterile injectable used in a procedure where precision is non-negotiable.
What the recall signals for ophthalmic supply chains
This notice shows how product quality issues in injectable ophthalmology can arise outside the active ingredient itself. Aflibercept remains the medicine at the center of care, but the syringe platform is the delivery vehicle, and delivery integrity is inseparable from safe use. For dispensing GP practices, pharmacies, and NHS regional teams, the message is straightforward: identify the affected batches, stop supply, quarantine stock, and forward the notice to relevant contacts.
The MHRA has also provided contact details for product enquiries through Advanz Pharma, including medical information by email and telephone. Those channels are intended to support professional clarification while the recall is implemented across the supply chain.
This recall is limited to specific batches and is precautionary, but it leaves an important operational question for services that administer intravitreal therapy: how quickly can a packaging-related defect be detected, isolated, and removed before it reaches a procedure room?