Class II · Moderate risk
Fluticasone Propionate Nasal Spray USP
CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
Is Fluticasone recalled?
Yes — there is an active recall. 3 ongoing FDA recalls mention Fluticasone (22 total). Check the affected lots below.
Most common reason: Wrong potency / content (5 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Fluticasone. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Fluticasone recalls on record
none so far in 2026; 22 on record, newest first
Class II · Moderate risk
Fluticasone Propionate Nasal Spray USP 50mcg
CGMP Deviations: potential presence of Burkholderia cepacia complex
Class II · Moderate risk
Fluticasone Propionate Nasal Spray
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Fluticasone Propionate Nasal Spray
Defective container: defect prevents product from dispensing as intended.
Class II · Moderate risk
Inhub Wixela
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
Fluticasone Propionate Nasal Spray USP
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
AirDuo Digihaler 232/14
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class II · Moderate risk
AirDuo Digihaler 113/14
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class II · Moderate risk
AirDuo Digihaler 55/14
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class II · Moderate risk
AirDuo Digihaler 232/14
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class II · Moderate risk
AirDuo Digihaler 113/14
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class II · Moderate risk
Trelegy Ellipta
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Trelegy Ellipta
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Arnuity Ellipta
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Dymista (azelastine hydrochloride and fluticasone propionate)
Defective Container: Potential for broken glass in the neck area of the glass bottles.
Class II · Moderate risk
Dymista (azelastine hydrochloride and fluticasone propionate)
Presence of foreign substance: Potential for glass in the neck area of the glass bottles.
Class II · Moderate risk
Fluticasone propionate Nasal Spray
Presence of foreign substance: glass particles
Class II · Moderate risk
Fluticasone propionate USP
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk
Fluticasone Propionate Nasal Spray
Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride.
Class II · Moderate risk
Fluticasone Propionate active pharmaceutical ingredient packaged…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class III · Low risk
Advair HFA
Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
Class III · Low risk
Advair HFA
Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
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