The Food and Drug Administration has announced the recall of a medication used to treat narcolepsy and ADHD after a pharmacist in Nebraska reporting finding a mislabeled bottle.

Instead of finding the medication listed on the bottle, 30 mg tablets of Zenzedi (dextroamphetamine sulfate), the pharmacist said it contained carbinoxamine meleate, an antihistamine.

What You Need To Know

  • The FDA has announced a recall of Zenzedi, a medication used to treat narcolepsy and ADHD

  • The recall of 30 mg pills was issued after a pharmacist found an antihistamine in a bottle labeled as Zenzedi

  • While Zenzedi pills are light yellow and hexagonal, the antimistamine pills are round and white|

  • Anyone in possession of the recalled medication is urged to stop taking it and return it to the pharmacy where it was purchased

"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," the FDA recall announcement said.

The manufacturer of Zenzedi, Azurity Pharmaceuticals, Inc., in Woburn, Mass., issued a voluntary recall of one lot of the medication, which was shipped to pharmacies nationwide.

The recall announcement warned that the antihistamine mistakenly labeled as Zenzedi could cause adverse effects, especially because it can cause drowsiness in the people taking it.

"For patients with Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy (sleep disorder) there is a reasonable probability that accidents or injuries that occur due to the sedating effects of carbinoxamine, could lead to ongoing disability or death in severe cases, particularly if individuals who use it (unaware that they have not received Zenzedi®) engage in activities requiring significant focus and alertness (e.g., driving, operating heavy machinery)," the FDA announcement said.

Thus far, the FDA notice said it has not received any reports of "serious adverse events related to this recall."

The pills in question were from lot number F230169A and have an expiration date of June 2025. They were shipped to wholesalers between Aug. 23 and Nov. 29, 2023.

For anyone concerned that they might have received the wrong medication, the FDA gave a description of the differences between Zenzedi and the antihistamine:

"Zenzedi® 30 mg tablets can be identified by light yellow hexagonal tablet debossed with “30” on one side and “MIA” on the other side and distributed in a white bottle with black writing and “30 mg” highlighted yellow. Whereas the description of the suspect tablets (Carbinoxamine Maleate Tablets USP, 4 mg), which was provided by the reporting pharmacist, was white round tablets with imprints of “GL” on one side and “211” on the other side."

Patients who have received the incorrect medication are urged to stop taking it and return it to the pharmacy where it was purchased.