Class II · Moderate risk
Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol…
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Is Formoterol recalled?
Not under an active recall.
Formoterol was recalled 7 times in the past — all now closed. Most recent: Mar 15, 2021.
Most common reason: Stability / shelf life (3 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Formoterol. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Formoterol recalls on record
none so far in 2026; 7 on record, newest first
Class II · Moderate risk
Bevespi Aerosphere
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Formoterol 12mcg / Budesonide 0.5mg
Lack of Processing Controls
Class III · Low risk
Foradil Aerolizer
Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.
Class III · Low risk
Foradil Aerolizer
Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.
Class II · Moderate risk
Formoterol Fumarate Dihydrate active pharmaceutical ingredient…
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
Foradil Aerolizer
Failed Stability Specification; out of specification result for particle size distribution during stability testing
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