Voluntary nationwide recall: Zenzedi (Azurity - January)

Azurity Pharmaceuticals Inc. is recalling one lot of Zenzedi tablets, USP 30 mg. Zenzedi is used for the treatment of narcolepsy (a sleep disorder) and attention deficit hyperactivity disorder (ADHD).

This drug is being recalled because tablets of Carbinoxamine Maleate, an antihistamine drug, were found in a Zenzedi bottle during pharmacy dispensing. Patients who 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. Administration of Carbinoxamine may cause adverse events which include, but are not limited to, drowsiness, sleepiness, central nervous system (CNS) depression, increased eye pressure, enlarged prostate urinary obstruction, and thyroid disorder.

As of the date of Azurity’s recall announcement, Jan. 24, 2024, there have been no reports of adverse events related to this recall. To see if your medication was recalled, contact your doctor or pharmacy where you received the medication or visit the FDA website below.

If you have an affected lot of Zenzedi, you should stop using the item and return it to the place of purchase.

To learn more about this recall, you can take one or more of the steps below.

• Talk to your doctor or pharmacist.
• Call Inmar Intelligent at 1-877-804-2069. TTY users should call 711. Help is available Monday through Friday from 9 a.m. to 5 p.m. EST.
• Visit the FDA website.