Class II · Moderate risk
Budesonide Inhalation Suspension
Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution
Is Budesonide recalled?
Yes — there is an active recall. 4 ongoing FDA recalls mention Budesonide (22 total). Check the affected lots below.
Most common reason: cGMP deviation (7 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Budesonide. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Budesonide recalls in 2026
1 initiated in 2026, 22 in total — newest first
Class II · Moderate risk
Budesonide Inhalation Suspension
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Class II · Moderate risk
Airsupra (albuterol and budesonide)
Defective delivery system
Class II · Moderate risk
Budesonide
CGMP Deviations and Presence of Particulate Matter: Glass
Class II · Moderate risk
Budesonide Extended-Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Budesonide Extended-Release Tablets 9mg
Failed Dissolution Specifications
Class II · Moderate risk
Budesonide Inhalation Suspension 0.25mg/2mL
Lack of Assurance of Sterility
Class II · Moderate risk
Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol…
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Albuterol 1.25mg / Ipratropium 0.5mg/ Budesonide 0.25mg
Lack of Processing Controls
Class II · Moderate risk
Albuterol 2.5mg / Budesonide 0.5mg
Lack of Processing Controls
Class II · Moderate risk
Albuterol 2.5mg / Ipratropium 0.75mg /Budesonide 0.25mg
Lack of Processing Controls
Class II · Moderate risk
Albuterol 2.5mg / Ipratropium 0.75mg /Budesonide 0.5mg
Lack of Processing Controls
Class II · Moderate risk
Budesonide 0.4mg
Lack of Processing Controls
Class II · Moderate risk
Formoterol 12mcg / Budesonide 0.5mg
Lack of Processing Controls
Class II · Moderate risk
All budesonide Products
Lack of Processing Controls
Class II · Moderate risk
c-Budesonide 0.6MG capsules
Penicillin Cross Contamination - Possible presence of penicillin in bulk budesonide powder used to compound prescription nasal rinse/nebulizer capsules.
Class II · Moderate risk
Budesonide active pharmaceutical ingredient packaged in varying…
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
Budesonide Capsules
Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an out-of-specification (OOS) result for dissolution testing.
Class III · Low risk
PULMICORT RESPULES 0.5 mg/2 ml
Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.
Class III · Low risk
PULMICORT RESPULES 0.25 mg/2 ml Budesonide Inhalation Suspension
Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.
Class II · Moderate risk
Budesonide
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Class II · Moderate risk
Tobramycin 1.4%
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
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