Clobazam Martindale oral suspension: Class 4 barcode notification
17 September 2026
On 17 September 2026 the MHRA issued a Class 4 Medicines Defect Notification, EL(26)A/38, for Clobazam Martindale Pharma 5mg/5mL and 10mg/5mL oral suspension in 150mL bottles. The marketing authorisation holder is Martindale Pharmaceuticals Ltd, and the notice carries the reference DMRC-40754020.
What the notice says
Martindale told the MHRA that the cartons of some batches carry an incorrect pre-printed linear barcode. The barcode represents the GTIN for the branded version of the product, Tapclob, rather than the generic name clobazam. The code in the 2D printed barcode is correct, and the strength and bottle size printed on the pack are unchanged.
The notice lists three batches. For the 5mg/5mL suspension they are 0162858 (expiry 05/2028, first distributed 18 August 2026) and 0163605 (expiry 07/2028, first distributed 14 September 2026). For the 10mg/5mL suspension the batch is 0163858 (expiry 07/2028, first distributed 14 September 2026). Martindale says future batches of both strengths will have the barcode corrected with a sticker until new cartons are available.
The notice states that there is no risk to product quality and that the batches are not being recalled. It advises healthcare professionals to note the batches and to use the serialised 2D barcode for authentication and traceability. The linear barcode on the carton should not be used for product identification, and the notice says wholesalers and pharmacies that use the linear barcode in a wholesale facility should consider additional precautions.
What the four notice classes mean
The MHRA publishes a classification table for its recalls and notifications. A Class 1 recall, issued as a National Patient Safety Alert, covers a defect that presents a risk of death or disability. A Class 2 recall covers a defect that may cause mistreatment or harm to the patient but is not life-threatening or serious. A Class 3 recall covers a defect unlikely to cause harm, where the recall is carried out for other reasons such as non-compliance with the marketing authorisation or specification.
Class 4 is a notification, not a recall. The MHRA describes it as a caution in use notice, generally for minor defects in packaging or other printed material, or where a defect has been found but supply concerns mean the product cannot be recalled. Each notice sets out its own actions for dispensaries, and the table does not set them out for the class as a whole. Our earlier note on the Class 2 fingolimod recall covers a notice from the recall side of the table.
The full notice is on GOV.UK.