Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Advair HFA (fluticasone propionate 45 mcg and salmeterol 21 mcg) Recalled by GlaxoSmithKline, LLC. Due to Product Lacks Stability: These lots are being recalled...

Date: October 24, 2012
Company: GlaxoSmithKline, LLC.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact GlaxoSmithKline, LLC. directly.

Affected Products

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.

Quantity: 310,964 Aerosol Units

Why Was This Recalled?

Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About GlaxoSmithKline, LLC.

GlaxoSmithKline, LLC. has 11 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report