What is Fluticasone?
Fluticasone is a corticosteroid medication available in several forms, including nasal sprays and inhalers. It is primarily used to treat inflammatory conditions. Fluticasone propionate nasal spray is a common treatment for seasonal and perennial allergic rhinitis, helping to relieve symptoms like sneezing, itchy or runny nose, and sinus pressure. Other forms, such as fluticasone furoate, also exist. The medication works by reducing swelling and irritation in the nasal passages. However, like any pharmaceutical product, specific batches can be subject to recall for quality or safety concerns. Consumers should be aware of these historical and recent events to ensure the safety of their medication.
Past and Recent Fluticasone Recalls
Several recalls concerning fluticasone have been issued in recent years, primarily involving generic versions of the nasal spray. These events are often triggered by specific lot numbers or manufacturing-related issues. The FDA tracks these recalls and issues alerts.
Notable Fluticasone Recalls:
- February 2024 (Apotex Corp.): Voluntary recall of one batch of Fluticasone Propionate Nasal Spray USP due to suspected potential presence of Burkholderia cepacia complex (BCC). This was a precautionary retail/pharmacy level recall.
- May 2023 (Akorn Operating Company LLC): Nationwide voluntary recall of several drug products, including fluticasone propionate nasal suspension. This was due to the company filing for bankruptcy and ceasing operations, making it unable to guarantee product quality through the labeled shelf life.
- July 2022 (Akorn, Inc.): Recall for Fluticasone Propionate Nasal Spray 50 mcg due to a defective container that prevented proper dispensing.
- May/June 2018 (Apotex Corp.): Recall of one lot (lot number NJ4501, expiration date 07/2020) of Fluticasone Propionate Nasal Spray USP 50 mcg due to the potential presence of small glass particles in the spray bottles. The risk included pump malfunction and potential mechanical irritation to the nasal mucosa from glass particles.
Checking Your Medication for Recalls
To determine if a specific product you own is subject to a recall, follow these steps:
- Check the manufacturer: Recalls are often specific to a manufacturer. Locate the manufacturer's name on the packaging.
- Verify the lot number and expiration date: Recalls target specific lots or batches. Find this information on the packaging or bottle.
- Search the FDA database: The U.S. Food and Drug Administration (FDA) website contains detailed drug recall information.
- Contact your pharmacy: Your pharmacist can provide the latest recall notices and guidance.
Comparison of Major Fluticasone Recalls
| Recall Date | Manufacturer | Reason for Recall | Impact on Patients |
|---|---|---|---|
| Feb 2024 | Apotex Corp. | Potential Burkholderia cepacia complex contamination. | No adverse events reported; precautionary measure. |
| May 2023 | Akorn Operating Co. | Company bankruptcy; inability to guarantee product quality. | Products could not be guaranteed to meet quality standards. |
| July 2022 | Akorn, Inc. | Defective container. | Product could not be dispensed properly. |
| May 2018 | Apotex Corp. | Presence of glass particles. | Potential mechanical irritation or pump malfunction. |
Conclusion
Multiple specific recalls of fluticasone nasal sprays have occurred in the past, issued by manufacturers like Apotex and Akorn, due to issues ranging from potential contamination to packaging defects and company bankruptcy. As of late 2025, there is no new widespread recall on all fluticasone products. Consumers should check their product's manufacturer, lot number, and expiration date against official FDA recall notices or consult with a pharmacist to ensure the safety of their medication.
Frequently Asked Questions
- Is all fluticasone subject to recall? No. Recalls are specific to particular manufacturers and lot numbers, not all versions or brands of fluticasone. Brand names like Flonase, for instance, are not currently under widespread recall for the issues faced by generic versions.
- What should I do if I have a recalled product? Stop using the product immediately. Contact the manufacturer using the number on the recall notice or contact your pharmacy for guidance on returning the item and getting a replacement.
- Can recalled fluticasone cause health problems? In past recalls, risks have included mechanical irritation from glass particles and potential exposure to bacteria, though adverse events have been rare or not reported. Always consult your healthcare provider if you have any health concerns related to a recalled product.
- Is it safe to use fluticasone from other brands? Yes, if a recall only affects a specific brand or lot number, other brands or lots not named in the recall are considered safe for use. Always verify with your pharmacy if you are unsure.
- How do I check the lot number and expiration date? This information is typically printed on the medication box, bottle, or container. It is often located near the barcode or manufacturer's details. The lot number may be labeled "Lot," "Batch," or "Control Number".
- Are over-the-counter (OTC) and prescription fluticasone recalls different? Recalls can apply to both OTC and prescription versions, depending on the manufacturer and the specific product. Recall notices will specify if an OTC or prescription product is affected.
- Where can I find reliable information on current recalls? The U.S. Food and Drug Administration (FDA) website is the most reliable source for official recall announcements. You can also contact your pharmacist directly.
