MHRA Class 2 Medicines Recall: Baclofen 10mg/5ml Oral Solution (Syri Limited, T/A SyriMed)

Drug alert number: EL(26)A/06

Date issued: 3 February 2026

Syri Limited, T/A SyriMed is recalling batches of product as a precautionary measure due to crystallisation observed over time in the oral solution.

DMRC reference number: DMRC-38317957

Company name:Syri Limited, T/A SyriMed

Medicine Details

Baclofen 10mg/5ml Oral Solution (PL: 39307/0090)

Active ingredient: baclofen

SNOMED code: 38757711000001104

GTIN: 5055935104700

Affected Lot Batch Numbers:

Batch No. Expiry Date Pack Size First Distributed
EBB25001A1 31/03/2027 150ml 30/07/2025
EBB24001A1 30/09/2026 150ml 17/02/2025

Background

Syri Limited, T/A SyriMed is recalling the above batches of product as a precautionary measure due to crystallisation observed over time in the oral solution. Testing results show that the assay of the filtered oral solution does not comply with the licensed specification of the product and there is a potential risk of sub-therapeutic dosing. The recall is at pharmacy and wholesaler level.

Advice for Healthcare Professionals

Stop supplying the above batches immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.

View the full alert here.

Advice for Patients

No further action is required by patients as this is a pharmacy and wholesaler level recall. Patients should continue to take medicines from these batches as prescribed by your healthcare professional.

Do not stop taking baclofen suddenly without medical advice as you may get withdrawal side effects.

Patients who experience adverse reactions or have any questions about the medication, should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme on https://yellowcard.mhra.gov.uk/

Additional information

For medical information enquiries please use the following options:

Email: medinfo@syrimed.co.uk, or telephone +44 (0) 330 1359 422.

For stock control enquiries please email syriwholesale@bnsthamelabs.com

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