RecallClass 4 · Caution in use

Class 4 Medicines Defect Notification: Flamingo Pharma UK Ltd, Amitriptyline Hydrochloride 10mg, 25mg, 50mg Tablets, EL(25)A/52

Issued 10 Dec 2025 · EL(25)A/52 · Flamingo Pharma UK Ltd

Read and act on the official notice on GOV.UK

Class 4 recall — Caution in use. The MHRA uses Class 4 when: Usually minor defects in packaging or other printed materials.
What all four recall classes mean
ClassActionThe MHRA's definition
Class 1Immediate actionThe defect presents a risk of death or disability.
Class 2Action within 48 hoursThe defect may cause mistreatment or harm to the patient, but it is not life-threatening or serious.
Class 3Action within 5 daysThe defect is unlikely to cause harm to the patient.
Class 4 this recallCaution in useUsually minor defects in packaging or other printed materials.

A Class 1 recall usually comes with a National Patient Safety Alert. Source: MHRA, safety communications.

The MHRA's summary

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.

Affected batches

As listed by the MHRA, exactly as published. Always check against the GOV.UK notice before acting.

Batch numberExpiryPack sizeFirst distributed
Amitriptyline Hydrochloride 10mg Tablets
140451531/12/20252810/03/2023
140453931/12/20252829/03/2023
140454031/12/20252826/05/2023
140454631/12/20252830/05/2023
140472131/03/20262818/07/2023
140472231/03/20262819/07/2023
Amitriptyline Hydrochloride 25mg Tablets
140462828/02/20262819/05/2023
140463028/02/20262819/05/2023
140463128/02/20262822/05/2023
140463228/02/20262822/05/2023
140464028/02/20262821/06/2023
140464128/02/20262821/06/2023
140462928/02/20262810/08/2023
Amitriptyline Hydrochloride 50mg Tablets
140461531/01/20262817/05/2023
140461631/01/20262817/05/2023
140462631/01/20262815/06/2023
140462731/01/20262815/06/2023
140472431/03/20262810/07/2023
140472330/04/20262810/08/2023

MHRA's audience tags: Dispensing GP practices, Pharmacy

Pharmshark is not an official alerting route. Make sure your pharmacy receives alerts directly from the MHRA and through your organisation, and always act on the official GOV.UK notice.

Source: the MHRA on GOV.UK. Contains public sector information licensed under the Open Government Licence v3.0. Pharmshark is not affiliated with or endorsed by the MHRA.