Baclofen Oral Solution Recall EL(26)A/06: Crystallisation Risk in SyriMed Batches

What Has Been Recalled and Why

Syri Limited, operating as SyriMed, has recalled batches of Baclofen 10mg/5ml Oral Solution following reports of crystallisation developing over time within the product. The recall is classified as Class 2 by the MHRA under reference EL(26)A/06.

Crystallisation in an oral solution is a physical instability finding. It occurs when the dissolved active ingredient precipitates out of solution and forms solid crystals visible within the liquid. For baclofen oral solution, this has significant implications for dosing accuracy. If crystals have formed, the concentration of baclofen remaining dissolved in the liquid may be lower than intended, meaning a measured dose could deliver less active drug than expected. Conversely, if the crystals are disturbed or incompletely dissolved before administration, the dose could be unpredictable.

Baclofen is used to treat muscle spasticity in conditions including multiple sclerosis, cerebral palsy, and spinal cord injury. The oral solution formulation is typically used by patients who cannot manage tablet dosing, often those with complex neurological conditions who may already have difficulty communicating symptoms of underdosing.

The Clinical Risk of Baclofen Underdosing

Baclofen acts on GABA-B receptors in the spinal cord to reduce muscle tone and spasticity. Patients titrated onto stable baclofen doses often have carefully managed regimens that have been optimised over time. Underdosing, even temporarily, can result in a rapid return of painful spasms, loss of functional mobility, and in severe cases, autonomic dysreflexia in spinal cord injury patients.

Equally concerning is the risk of abrupt discontinuation. If a patient receiving baclofen suddenly has their supply removed due to a recall with no immediate alternative, the consequences can be serious. Baclofen withdrawal can cause seizures, hallucinations, hyperthermia, and rebound spasticity. This is not a medicine where supply continuity can be treated as a low priority.

Pharmacy and prescribing teams must ensure that patients on the recalled SyriMed baclofen oral solution are identified quickly and that an alternative source is secured before their current supply runs out.

Immediate Steps for Pharmacy Teams

1. Quarantine all affected SyriMed baclofen oral solution stock. Remove from dispensing immediately and label clearly as recalled product.
2. Identify patients currently receiving this product. Check dispensing records and patient medication administration records to identify all individuals at risk.
3. Notify prescribers and clinical teams without delay. Neurologists, GPs, and care teams need to know so they can ensure continuity of treatment.
4. Source alternative baclofen oral solution urgently. Other specials manufacturers produce baclofen 10mg/5ml oral solution and may be able to supply. An MHRA-licensed wholesale dealer can help identify available stock.
5. Do not discontinue baclofen without medical supervision. If alternative supply cannot be immediately obtained, the clinical team must manage a supervised reduction or bridge with another formulation if appropriate.

Sourcing Alternative Baclofen Oral Solution

Baclofen oral solution is produced by several MHRA-licensed specials manufacturers in the UK. This recall is specific to batches from Syri Limited (SyriMed) and does not affect product from other licensed manufacturers. Alternative supply should be available through the specials supply network.

Euro Biom is an MHRA WDA-licensed wholesale exporter. While our primary focus is international pharmaceutical export, we maintain supplier relationships across the UK pharmaceutical market and can assist procurement teams in identifying sources of baclofen oral solution following supply disruptions. Contact us with your requirement and we will work to help identify available stock as quickly as possible.