NAFDAC Warns Nigerians About Suspected Counterfeit Pulmicort® Asthma Medicine in Circulation

The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a public alert after a suspected counterfeit version of Pulmicort® (Budesonide) Inhalation Suspension was discovered in the Nigerian market. The alert followed information provided by AstraZeneca during market surveillance activities, which identified a product marketed as “Ulmicort 0.5 mg/ml Inhalation Suspension” that closely resembles the genuine Pulmicort® medicine. NAFDAC is investigating the source and distribution of the suspected counterfeit product while carrying out nationwide surveillance to remove it from circulation.

Me & You Pharma Takeaways

• NAFDAC has detected a suspected counterfeit asthma medicine marketed as Ulmicort 0.5 mg/ml Inhalation Suspension.
• The counterfeit product closely resembles the genuine Pulmicort® (Budesonide) Nebulising Suspension manufactured by AstraZeneca.
• Genuine Pulmicort® is prescribed to help prevent asthma symptoms such as wheezing and shortness of breath.
• Counterfeit medicines may contain the wrong ingredients, incorrect doses, contaminants, or no active ingredient at all.
• The suspected counterfeit product was identified in Eastern Nigeria and is currently under investigation.
• Patients should only buy medicines from licensed pharmacies and report any suspected counterfeit medicines to NAFDAC.

What Happened?

NAFDAC announced that AstraZeneca notified the agency of a suspected counterfeit product discovered during routine market surveillance. The product, labelled “Ulmicort 0.5 mg/ml Inhalation Suspension,” bears a name and appearance similar to the registered Pulmicort® (Budesonide) Nebulising Suspension, which may mislead healthcare professionals and patients.

The suspected counterfeit product was reportedly found in Eastern Nigeria, with a distributor address listed in Awada, Obosi North, Anambra State. According to the product label, it bears batch number 25770416E, a manufacturing date of June 2025, and an expiry date of May 2027.

NAFDAC has directed all zonal directors and state coordinators to intensify surveillance and remove any counterfeit products found in circulation while investigations continue.

Why It Matters To Your Health

Pulmicort® contains budesonide, an inhaled corticosteroid used to control asthma by reducing inflammation in the airways. It is prescribed as a long-term maintenance treatment to help prevent symptoms such as wheezing, coughing, chest tightness, and shortness of breath.

Counterfeit medicines can put patients at serious risk because they may not contain the correct amount of the active ingredient—or may contain harmful contaminants or entirely different substances. If an asthma patient unknowingly uses a counterfeit inhalation medicine, their asthma symptoms may not be adequately controlled, increasing the risk of severe asthma attacks and emergency hospital visits.

Children and adults who depend on inhaled corticosteroids for daily asthma management are particularly vulnerable to treatment failure if they receive falsified medicines. Prompt identification and removal of counterfeit medicines help protect patients and maintain confidence in legitimate healthcare products.

What You Can Do

To reduce your risk of purchasing counterfeit medicines:

• Buy asthma medicines only from licensed pharmacies and authorized medicine distributors.
• Carefully check the product name, packaging, manufacturer details, batch number, and expiry date before using any medicine.
• Be cautious of medicines with names that closely resemble well-known brands.
• If you notice differences in packaging or suspect a medicine may be counterfeit, do not use it until you have consulted a pharmacist.
• Continue taking your prescribed asthma medication unless advised otherwise by your healthcare provider.
• Report suspected counterfeit medicines to the nearest NAFDAC office or through NAFDAC’s reporting channels.

Understanding The Issue

Counterfeit medicines are products that deliberately misrepresent their identity, composition, or source. They are manufactured or packaged to resemble genuine medicines, making them difficult for patients to distinguish without careful inspection.

In this case, the suspected counterfeit product uses the name “Ulmicort,” which closely resembles Pulmicort®, a medicine widely prescribed for asthma management. Such similarities may confuse patients, caregivers, and even healthcare providers, increasing the likelihood that the counterfeit product will be purchased or dispensed.

Pulmicort® contains budesonide, a corticosteroid that works by reducing inflammation inside the lungs. Unlike quick-relief inhalers that treat sudden asthma attacks, budesonide is used regularly to prevent asthma symptoms and reduce the frequency of flare-ups. Missing doses or using an ineffective counterfeit medicine may leave asthma poorly controlled and increase the risk of severe exacerbations.

One of the greatest dangers of counterfeit medicines is that patients often do not realize they are using a falsified product until treatment fails or unexpected side effects occur. Counterfeit medicines may contain too little of the active ingredient, the wrong ingredient altogether, harmful contaminants, or no active ingredient at all.

The discovery of the suspected counterfeit Pulmicort® highlights the importance of purchasing medicines through legitimate supply chains. Licensed pharmacies source medicines from authorized distributors and are better positioned to identify suspicious products than informal vendors or unauthorized sellers.

NAFDAC’s ongoing investigation and nationwide surveillance demonstrate the agency’s commitment to protecting Nigerians from falsified medicines. Healthcare professionals also play a critical role by remaining vigilant, examining medicine packaging carefully, and reporting suspicious products promptly.

When To Speak With A Healthcare Professional

Speak with your pharmacist or doctor if:

• You are unsure whether your Pulmicort® inhalation suspension is genuine.
• You notice unusual packaging, labeling, or product appearance.
• Your asthma symptoms worsen despite using your prescribed inhaler correctly.
• You experience unexpected side effects after using an inhalation medicine.
• You need advice on safely replacing a suspected counterfeit product.

Seek emergency medical attention immediately if you develop severe difficulty breathing, persistent wheezing, chest tightness that does not improve with your rescue inhaler, bluish lips or fingertips, or any signs of a severe allergic reaction.

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Medical Disclaimer

This content is provided for educational purposes only and is not intended to replace professional medical advice, diagnosis, or treatment. Always consult a qualified healthcare professional before starting, stopping, or changing any medication or treatment plan.