Medication recalls are a critical safety measure to protect the public from potentially harmful or defective products [1.6.2]. The U.S. Food and Drug Administration (FDA) oversees this process, which can be initiated by the manufacturer or mandated by the FDA itself [1.6.2]. For the millions of people who rely on inhalers to manage respiratory conditions like asthma and Chronic Obstructive Pulmonary Disease (COPD), a recall can be a significant concern. Staying informed about recent recalls is essential for patient safety.
Recent Inhaler Recalls (2024–2025)
In the past two years, several prominent pharmaceutical companies have issued recalls for various inhaler products. These actions were taken due to a range of issues affecting product safety and efficacy.
AstraZeneca Airsupra Recall (May 2025)
AstraZeneca recalled over 235,000 units of its Airsupra (albuterol and budesonide) inhalation aerosol across three specific lots [1.2.2]. The recall, initiated on May 14, 2025, was designated as a Class II event by the FDA. The stated reason was a "Defective delivery system," which could potentially lead to the device not delivering the correct dose of medication [1.2.2, 1.6.5]. Airsupra is a dual-action rescue inhaler used to relax airway muscles and reduce lung inflammation [1.2.2].
Cipla Albuterol and Ipratropium Bromide Recalls (2024-2025)
Cipla USA has been involved in multiple recalls. In March 2024, the company recalled two lots of ipratropium bromide and albuterol sulfate inhalation solution due to customer reports of low fill levels in the respules [1.2.1]. This was also a Class II recall. More recently, in August 2025, Cipla initiated a Class III recall for a specific lot of Albuterol Sulfate Inhalation Aerosol (90 mcg) [1.4.2]. This was prompted by stability testing failures that showed the product did not meet particle size distribution specifications after 12 months [1.4.2]. A Class III recall indicates that the use of the product is unlikely to cause adverse health consequences [1.6.2].
Teva Digihaler Market Withdrawal (June 2024)
Teva Pharmaceuticals conducted a nationwide market withdrawal for all its Digihaler products, including ProAir, AirDuo, and ArmonAir, that were within their expiry dates [1.5.5]. This was not a recall based on the medication's safety but because the accompanying mobile app and dashboard were no longer available. Since the app's use was part of the patient information leaflet, the products were withdrawn [1.5.5].
Comparison of Recent Inhaler Recalls & Withdrawals
| Product (Manufacturer) | Type of Action | Reason for Action | Date of Action | FDA Class |
|---|---|---|---|---|
| Airsupra (AstraZeneca) | Recall | Defective delivery system [1.2.2] | May 2025 | Class II [1.2.2] |
| Albuterol Sulfate Aerosol (Cipla) | Recall | Failed particle size stability tests [1.4.2] | August 2025 | Class III [1.4.2] |
| Ipratropium/Albuterol Solution (Cipla) | Recall | Low fill volume in respules [1.2.1] | March 2024 | Class II [1.2.1] |
| Digihaler Products (Teva) | Market Withdrawal | Discontinuation of required app/dashboard [1.5.5] | June 2024 | N/A [1.5.5] |
Understanding FDA Recall Classifications
The FDA categorizes recalls into three classes based on the potential health hazard [1.6.2]:
- Class I: The most serious category. There is a reasonable probability that using the product will cause serious adverse health consequences or death [1.6.4].
- Class II: The product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote [1.6.4]. The AstraZeneca and one of the Cipla recalls fall into this category [1.2.1, 1.2.2].
- Class III: Use of the product is not likely to cause adverse health consequences [1.6.4]. The August 2025 Cipla recall is an example [1.4.2].
What Should You Do if Your Inhaler is Recalled?
If you discover your medication is part of a recall, it's important to act calmly and methodically.
- Check Lot Numbers: First, identify the lot number on your inhaler's packaging or on the canister itself. Compare it to the lot numbers listed in the official recall notices from the FDA [1.7.4]. Your pharmacy can also help verify if your specific prescription is affected [1.6.5].
- Do Not Stop Treatment Abruptly: Unless specifically instructed to do so, do not stop taking a life-sustaining medication [1.7.2, 1.7.4]. Suddenly discontinuing treatment for a condition like asthma or COPD can be dangerous [1.7.4].
- Consult Your Healthcare Provider: Contact your doctor or pharmacist immediately [1.7.5]. They can advise on the specific risks associated with the recall, determine if you need to switch medications, and prescribe an alternative if necessary [1.7.4].
- Follow Disposal Instructions: The recall notice will provide instructions on what to do with the affected product, which may include returning it to the pharmacy [1.4.6]. Do not simply throw medication in the trash unless you follow specific FDA guidelines, such as mixing it with an unpalatable substance like coffee grounds and sealing it in a bag [1.7.4].
Conclusion
While medication recalls can be unsettling, they demonstrate that safety monitoring systems are working to protect patients [1.6.6]. Staying informed about which inhalers are being recalled is a key part of managing your respiratory health. Always check the FDA's website for the most current information and maintain an open dialogue with your healthcare providers about your medications and any concerns you may have.
For the most up-to-date information, you can visit the FDA Drug Recalls Database.
