Azurity Pharmaceuticals announced a nationwide recall of attention-deficit/hyperactivity disorder (ADHD) and narcolepsy drug Zenzedi, after reports that a different drug was found in a bottle labeled as Zenzedi.

A pharmacist in Nebraska noticed a bottle of 3omg Zenzedi tablets instead contained carbinoxamine maleate pills. Carbinoxamine maleate is an antihistamine — a genre of drug that treats allergies or allergic reactions — and has the opposite effect of a stimulant.

In a release recently posted on the Food and Drug Administration (FDA)’s website, Azurity noted that patients who mistakenly take carbinoxamine instead of Zenzedi “will experience undertreatment of their symptoms, which may result in functional impairment and an increased risk of accidents or injury.”

Some adverse events associated with a switch-up of the pills include drowsiness, central nervous system depression, increased eye pressure and sleepiness, among others. 

Azurity noted that ADHD or narcolepsy patients may be at risk of disability or death in severe cases if they accidentally take carbinoxamine instead of Zenzedi — particularly in cases where they need to be focused, such as driving or operating machinery.

The announcement and recall come as the nation faces a widespread ADHD medication shortage, which has been ongoing since 2022. Shortages have affected Adderall, Ritalin, Concerta, Focalin and Vyvanse along with their generic counterparts, with many patients struggling to get access to the drugs at their pharmacies.

The drug shortage problem is also affecting other therapeutic areas, including diabetes, cancer and syphilis. 

In January, the FDA sought to partner with a French pharma company to alleviate the shortage of syphilis drug Bicillin L-A, which is manufactured by Pfizer. The FDA allowed Paris-based Laboratoires Delbert to temporarily import extencilline to the U.S.

Even as some lawmakers have sought to enact legislation that would begin addressing the drug shortage issue, not much has materialized. 

In a fireside chat on Wednesday, FDA commissioner Robert Califf noted that drug shortages — particularly among generics — was an “economic failure” and that he planned to “keep the heat on” politicians to pass legislation.

Azurity added that consumers should stop using their 30 mg Zenzedi pills and return them to their “place of purchase.” Patients who are experiencing any adverse reactions or quality problems, meanwhile, should report it to the FDA’s MedWatch program.