Mislabeled Packaging Results in Recalled ADHD Medication

On January 24, 2024, Azurity Pharmaceuticals sent an announcement to the United States FDA recalling Zenzedi, a brand name for 30 mg dextroamphetamine sulfate tablets, for mislabeled packaging. The recall applies to the F230169A lot, which was shipped between August 23, 2023, and November 29, 2023, with an expiration date of July 2025.

The company’s press release noted that a Nebraska pharmacist opened a bottle of Zenzedi and, instead of dextroamphetamine sulfate, found that an antihistamine, carbinoxamine maleate, was in the bottle. Recognizing the risks associated with mislabeled packaging, the company issued a recall and arranged for wholesalers to return the products.

On a consumer level, the company is asking consumers to discontinue using the recalled products. Patients are urged to return the product to where they purchased it as the company works on delivering replacements to consumers and wholesalers.

This medication is a stimulant used to manage narcolepsy and attention deficit hyperactivity disorder (ADHD). The tablets should be light yellow hexagonal with “30” on one side and “MIA” on the other. However, the incorrect antihistamine tablets are white and round, with “GL” on one side and “211” on the other.

Dextroamphetamine sulfate is a stimulant that improves attention and focus. According to GoodRx, the drug is presumed to increase norepinephrine, dopamine, and serotonin levels.

For patients who need this medication, including individuals with ADHD or narcolepsy, replacing dextroamphetamine sulfate with carbinoxamine maleate can be dangerous. The antihistamine can cause drowsiness, sleepiness, central nervous system (CNS) depression, increased eye pressure, enlarged prostate urinary obstruction, and thyroid disorder in patients misusing the medication.

Additionally, forgoing the medications can result in unmanaged narcolepsy or ADHD, leading to accidents, injuries, or loss of focus and alertness.

While no one has reported severe adverse reactions, patients should evaluate their medications and contact their healthcare provider if they have been taking the mislabeled drug. Adverse drug reactions should also be reported to the company and the FDA’s MedWatch Adverse Event Reporting system.