Producer
Akorn Operating Company LLC (Bankrupt)
Former American specialty pharmaceutical company (HQ Lake Forest IL; filed Chapter 7 bankruptcy May 2023 and immediately shut down all operations); was the dominant US manufacturer of albuterol sulfate nebulizer solution (the liquid form of albuterol administered via nebulizer machine, commonly used for infants, young children, and patients unable to use pMDI inhalers). At the time of its bankruptcy and immediate shutdown, Akorn supplied approximately 50-60% of the US albuterol nebulizer solution market. The abrupt cessation of Akorn's manufacturing operations in May 2023 triggered an immediate national albuterol nebulizer shortage declared by FDA — hospitals reported being unable to source adequate albuterol nebulizer vials for pediatric asthma emergencies, ICU patients, and home nebulizer users. The shortage lasted several months and required FDA to exercise enforcement discretion to allow foreign-manufactured albuterol products to be imported. Akorn's collapse is the canonical recent case study of single-facility concentration creating a national pharmaceutical shortage. Akorn is included in the supply company record for historical documentation despite being defunct.
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Incident2023
In May 2023, Akorn Operating Company (Lake Forest IL) filed Chapter 7 liquidation bankruptcy and immediately ceased all pharmaceutical manufacturing operations — with no wind-down period, no inventory transfer, and no successor manufacturer in place. At the time of its shutdown, Akorn produced approximately 50-60% of US albuterol sulfate 0.083% inhalation solution (nebulizer vials) — the form of albuterol used by infants, young children, elderly patients, and mechanically ventilated ICU patients who cannot use pressurized inhalers. Within days of Akorn's closure, hospitals, pharmacies, and home health agencies reported inability to source adequate albuterol nebulizer supply. FDA declared an albuterol nebulizer shortage and began emergency procedures to allow foreign-manufactured albuterol (not FDA-approved for US sale) to be imported under enforcement discretion. The shortage lasted multiple months into the 2023 fall respiratory illness season. Akorn's immediate shutdown is a case study in how bankruptcy-driven plant closures can instantly eliminate a dominant fraction of a critical medication's supply with no transition period — unlike a planned shutdown which gives FDA and manufacturers months to prepare.
American Society of Health-System Pharmacists ↗