CLASS III Drug recall · Reported 5 Dec 2012 · FDA Enforcement Report
Advair HFA (fluticasone propionate 45 mcg recalled by GlaxoSmithKline
GlaxoSmithKline is recalling Advair HFA (fluticasone propionate 45 mcg and salmeterol 21 mcg) Inhalation Aerosol, 120, distributed nationwide in the US. The recall was initiated on 24 Oct 2012 and the FDA has classified it as Class III.
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-064-2013
- FDA event ID
- 63707
- Recalling firm
- GlaxoSmithKline, Zebulon, NC
- Brand
- Advair Hfa
- Manufacturer
- GlaxoSmithKline LLC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 24 Oct 2012
- FDA classified
- 23 Nov 2012
- Reported
- 5 Dec 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Nasal Sprays
Timeline
| 24 Oct 2012 | Recall initiated by company | |
| 23 Nov 2012 | Classified by FDA | +30 days |
| 5 Dec 2012 | 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
Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
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
Advair HFA (fluticasone propionate 45 mcg and salmeterol 21 mcg) Inhalation Aerosol, 12g, 120 Metered Actuations, For Oral Inhalation with Advair HFA actuator only, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0715-20.
Where it was distributed
Nationwide and Puerto Rico.
Questions about this recall
Why was it recalled?
Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
Which lots are affected?
Lot #: 1ZP2465, Exp Oct-12, 1ZP5224, Exp. Nov-12, 1ZP5455, 1ZP6916, Exp. Dec-12, 1ZP8042, 1ZP9593, Exp Jan-13, 1ZP9900, Exp. Mar-13, 1ZP1134, Exp. Apr-13, 1ZP3190, 2ZP6531, Exp. May-13, 2ZP6924, 2ZP7258, Exp. Jul-13, 2ZP1886, 2ZP9975, 2ZP0027, 2ZP9782, Exp. Sep-13, 2ZP1331, Exp. Oct-13, 2ZP2366, Exp. Nov-13.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
Other products in this recall event
1 other product · FDA event 63707| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Advair HFA (fluticasone propionate/salmeterol) Inhalation recalledAdvair Hfa | GlaxoSmithKline | Potency & Assay | Nationwide |
More recalls from GlaxoSmithKline
All 23| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension recalledTivicay | GlaxoSmithKline | Other | Nationwide |
| Drug | CLASS III | Anoro Ellipta (umeclidinium recalled by GlaxoSmithKlineAnoro Ellipta | GlaxoSmithKline | Potency & Assay | Nationwide |
| Drug | CLASS III | Tivicay (dolutegravir) Tablets 50 mg recalled by GlaxoSmithKlineTivicay | GlaxoSmithKline | Other | Nationwide |
| Drug | CLASS II | Ventolin HFA (albuterol sulfate) Inhalation recalled by GlaxoSmithKlineVentolin | GlaxoSmithKline | Potency & Assay | Nationwide |
| Drug | CLASS II | Ventolin HFA (albuterol sulfate) Inhalation Aerosol recalledVentolin | GlaxoSmithKline | Potency & Assay | Nationwide |
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 ApotexFluticasone Propionate | Apotex | Sterility | Nationwide |
| Drug | CLASS II | Fluticasone Propionate Nasal Spray recalled by Cardinal HealthcareFluticasone Propionate | 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 |