MHRA Class 2 Medicines Recall: Utrogestan Vaginal 200 mg Capsules (progesterone)

Drug alert number: EL (25)A/13

Date issued: 01 April 2025

Uni Health Distribution Ltd has informed the MHRA of a typographical error on the approved carton overlabel for certain batches of Utrogestan Vaginal 200 mg Capsules. The carton label references ‘micrograms’ where it should actually state ‘milligrams’.

Utrogestan Vaginal 200 mg Capsules, PLPI 45396/0316

Active ingredient: progesterone

Brief description of the problem

Uni Health Distribution Ltd has informed the MHRA of a typographical error on the approved carton overlabel for Utrogestan Vaginal 200 mg Capsules. The carton label references ‘micrograms’ where it should actually state ‘milligrams’.

Advice for healthcare professionals

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

Full drug alert can be viewed here.

Advice for patients

No further action is required by patients as this is a pharmacy and wholesaler level recall.

Patients should note that the correct typography ‘mg’ is referenced elsewhere on the carton label, as well as on the blister label and inside the PIL.

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.

Further Information

For further information and all enquiries please contact info@uhdltd.co.uk