Skip to content

This Site is Intended for Healthcare Professionals Only

Search AI Powered

Latest Stories

BREAKING: MHRA recalls Picato 150 mcg/g and 500 mcg/g gel

The Medicines and Health products Regulatory Agency (MHRA) today issued a class 2 medicines recall for Picato 150 mcg/g and 500 mcg/g gel.

LEO Pharma is recalling all unexpired stock of the products from pharmacies and wholesalers as a precautionary measure due to concerns on the possible risk of skin malignancy.


This is following the suspension of the marketing authorisation of Picato (ingenol mebutate), while the investigations are ongoing.

“Stop prescribing Picato and consider other treatment options as appropriate. For patients who have recently been prescribed Picato, advise patients to be vigilant for any skin lesions developing and to seek medical advice promptly should any occur,” the government agency advised healthcare professionals.

Pharmacists are asked to stop supplying the products immediately, quarantine remaining stock and return it to the supplier using the approved process.

Healthcare professionals are also asked to report any suspected adverse reactions via Yellow Card Scheme www.mhra.gov.uk/yellowcard or MHRA Yellow Card app.

Product details:

ProductMarketing Authorisation Number
Picato 150 mcg/g gel ▼EU/1/12/796/001
Picato 500 mcg/g gel ▼EU/1/12/796/002
Batch NumberExpiry DatePack SizeFirst Distributed
A69570AJan-203 x 0.47g tubes18-Apr-18
A69570BJan-203 x 0.47g tubes06-Jun-18
A72947AFeb-203 x 0.47g tubes06-Jun-18
A75024AApr-203 x 0.47g tubes18-Jul-18
A78808AMay-203 x 0.47g tubes05-Sep-18
A80602BJun-203 x 0.47g tubes12-Sep-18
A80602AJun-203 x 0.47g tubes12-Sep-18
A89440ANov-203 x 0.47g tubes22-Jan-19
A92248ADec-203 x 0.47g tubes11-Feb-19
A98938AMar-213 x 0.47g tubes16-May-19
C01098AApr-213 x 0.47g tubes24-Jun-19
C10894AAug-213 x 0.47g tubes22-Oct-19
C14179AOct-213 x 0.47g tubes06-Dec-19
A76669AApr-202 x 0.47g tubes22-Aug-18
A88113AOct-202 x 0.47g tubes11-Dec-18
A98419AMar-212 x 0.47g tubes16-May-19
C03413AMay-212 x 0.47g tubes29-Aug-19
C11902ASep-212 x 0.47g tubes08-Nov-19