Patients told to stop using four Flutiform batches after MHRA finds incorrect dose on label

A medical scare has prompted the urgent recall of multiple batches of a popular asthma inhaler after UK regulators discovered a serious labelling error that could have left patients unknowingly taking the wrong dosage.

The Medicines and Healthcare products Regulatory Agency (MHRA) issued a nationwide drug alert on Wednesday for Flutiform 250 micrograms / 10 micrograms per actuation inhalers, after the manufacturer, CD Pharma Ltd, reported a critical discrepancy on the product’s outer packaging.

While the total active content stated on the affected cartons is correct, the delivered dose—which patients actually inhale—was mislabelled. Although the medicine itself remains chemically sound and uncompromised, the misleading dosage figures have raised red flags for pharmacists, prescribers, and patients alike.

The incorrect label currently reads:

“Each metered dose (ex-valve) contains 250 micrograms of fluticasone propionate and 10 micrograms of formoterol fumarate dihydrate. This is equivalent to a delivered dose (ex-actuator) of approximately 115 micrograms of fluticasone propionate and 4.5 micrograms of formoterol fumarate dihydrate.”

But the correct delivered dose is 230 micrograms of fluticasone and 9 micrograms of formoterol—double what the faulty label states.

The MHRA acted swiftly once informed, confirming that four batches of the pressurised inhalation suspension are affected. These include:

• 270185-24062FA-30424 (Exp: 30 June 2026)
  
• 270186-24065FA-30443 (Exp: 30 June 2026)
  
• 270774-24082FB-30444 (Exp: 31 July 2026)
  
• 269881-24064FA-30425 (Exp: 30 June 2026)
  

All were first distributed between 30 June and 4 July 2025, each containing 120 actuations.

Pharmacy teams across the UK have been instructed to immediately quarantine all remaining stock, cease further dispensing, and return the affected inhalers using the MHRA’s authorised return process.

Though the integrity and safety of the medication itself is not in question, concerns remain that patients may have underestimated their dosage or that prescribers might have based decisions on incorrect delivery amounts.

The MHRA has not yet reported any adverse effects linked to the labelling mistake, but is continuing to monitor the situation closely.

This incident comes on the heels of another pharmaceutical disruption earlier this month when a limited supply warning was issued for a commonly used angina treatment. It underscores the fragile nature of medicine distribution chains and the importance of vigilance at every step—from production to patient.

Healthcare professionals are now tasked with alerting patients who may have received the flawed inhalers. It is unclear how many units were dispensed before the recall.

Anyone who suspects they’ve been given one of the affected batches is urged to contact their pharmacist immediately and not use the inhaler.