CLASS II Drug recall · Reported 11 Mar 2015 · FDA Enforcement Report
Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray recalled
Akorn is recalling Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, in amber with net fill weight, distributed nationwide in the US. The recall was initiated on 27 Feb 2015 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-0405-2015
- FDA event ID
- 70625
- Recalling firm
- Akorn, Lake Forest, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Feb 2015
- FDA classified
- 5 Mar 2015
- Reported
- 11 Mar 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Nasal Sprays
Timeline
| 27 Feb 2015 | Recall initiated by company | |
| 5 Mar 2015 | Classified by FDA | +6 days |
| 11 Mar 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, in amber glass bottle with net fill weight of 16 g that provides 120 actuations, Rx only, Manufactured by HI-TECH PHARMACAL CO., INC. Amityville, NY 11701 for Akorn Inc. 1925 W. Field Court, Suite 300 Lake Forest Illinois, 60045. NDC 50383-700-16.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride.
Which lots are affected?
Lot #: 631639, Exp 01/2017.
Where was it sold?
Nationwide and Puerto Rico
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 26 Sep 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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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 USP 50mcg recalled by Apotex | Apotex | 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 |