Class II · ModerateActive recall
Fluticasone Propionate Nasal Spray USP 50mcg
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot number # TX5274 Exp. 09/30/2026
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
CGMP Deviations: potential presence of Burkholderia cepacia complex
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byApotex Inc. Toronto, Ontario Canada M9L 1T9, Manufactured for: Apotex Corp Weston, FL 33326 foreign manufacturer
| Distributed by / for | Apotex Corp Weston, FL 33326 |
| NDC | 60505-0829-1 |
Show the full FDA record
| Full product label | Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net fill, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9, Manufactured for: Apotex Corp Weston, FL 33326. NDC 60505-0829-1 |
| Recalling firm | Apotex Corp. |
| Distribution | Nationwide in the USA |
| Quantity | 292,752 bottles |
| Recall initiated | 2024-02-09 |
| Report date | 2024-02-28 |
| Recall completed | — |
| Recall number | D-0326-2024 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Weston FL United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.