Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP
Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
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 Ipratropium. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
cGMP deviations: Temperature abuse
cGMP deviations: Temperature abuse
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Lack of Processing Controls
Lack of Processing Controls
Lack of Processing Controls
Lack of Processing Controls
Lack of Processing Controls
Lack of Processing Controls
Lack of Processing Controls
Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process
Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray.
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Label Mix up; side panel of sticker label applied by Dispensing Solutions Inc. incorrectly indicates product name as Ventolin HFA 90 mcg instead of correctly as Atrovent HFA 12.9 grams Inhalation Aerosol
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