Flamingo Pharma UK Ltd, Amitriptyline Hydrochloride 10mg, 25mg, 50mg tablets defect
Class 4 medicines defect notification: The MHRA has published a Class 4 medicines defect notification for Amitriptyline Hydrochloride 10mg, 25mg and 50mg tablets.
Published: 10 December 2025
The Medicines and Healthcare products Regulatory Agency (MHRA) has published a Class 4 medicines defect notification for Amitriptyline Hydrochloride 10mg, 25mg and 50mg tablets.
Flamingo Pharma UK Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in the products listed in this notification do not contain all the required safety information.
Further information, advice and details of the affected batches can be found on the MHRA website.