REGULATORY INTELLIGENCE·Recall
Aero Healthcare Initiates Class II Recall for AEROTAB PAIN RELIEVER Due to Critical Labeling Error
Aero Healthcare has issued a Class II recall for AEROTAB PAIN RELIEVER (NDC 55305-135) nationwide, initiated October 17, 2025. This stems from a critical labeling mix-up where outer packaging incorrectly lists Acetaminophen 500mg and Caffeine 65mg, while inner pouches correctly state Aspirin 500mg and Caffeine 32.5mg. This poses significant patient safety risks, demanding immediate attention from procurement and regulatory teams.
90-Day Activity