Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Is Salmeterol recalled?

Not under an active recall. Salmeterol was recalled 8 times in the past — all now closed. Most recent: Jan 26, 2022.

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 Salmeterol. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Salmeterol recalls on record

none so far in 2026; 8 on record, newest first
Class II · Moderate risk

Inhub Wixela

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Terminated Temperature excursion Cardinal Healthcare D-0202-2024
Class II · Moderate risk

AirDuo Digihaler 55/14

Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol

Terminated Wrong potency / content Teva Pharmaceuticals USA NDC 59310-111-06 D-0023-2022
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.

Terminated Stability / shelf life GlaxoSmithKline, LLC. NDC 0173-0715-22 D-065-2013
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.

Terminated Stability / shelf life GlaxoSmithKline, LLC. NDC 0173-0715-20 D-064-2013