CLASS II ONGOING Drug recall · Reported 28 Feb 2024 · FDA Enforcement Report
Fluticasone Propionate Nasal Spray USP 50mcg recalled by Apotex
Apotex is recalling Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - net fill, distributed nationwide in the US. The recall was initiated on 9 Feb 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0326-2024
- FDA event ID
- 93974
- Recalling firm
- Apotex, Weston, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Feb 2024
- FDA classified
- 16 Feb 2024
- Reported
- 28 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Nasal Sprays
Timeline
| 9 Feb 2024 | Recall initiated by company | |
| 16 Feb 2024 | Classified by FDA | +7 days |
| 28 Feb 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: potential presence of Burkholderia cepacia complex
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
CGMP Deviations: potential presence of Burkholderia cepacia complex
Which lots are affected?
Lot number # TX5274 Exp. 09/30/2026
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 1 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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| Drug | CLASS II | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%* recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution | Apotex | Sterility | Nationwide |
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Other Fluticasone Propionate recalls
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Fluticasone Propionate Nasal Spray USP, 50 mcg per spray recalledFluticasone Propionate | Golden State Medical Supply | Sterility | Nationwide |
| Drug | CLASS II | Fluticasone Propionate Nasal Spray recalled by Cardinal Healthcare | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Inhub Wixela (fluticasone propionate recalled by Cardinal HealthcareWixela Inhub | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Fluticasone Propionate Nasal Spray, 50mcg recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluticasone Propionate Nasal Spray recalled by Akorn | Akorn | Foreign Material | Nationwide |