A Nationwide Recall of 8,500 ADHD Medication Bottles Just Received an Update from the FDA

Though health experts estimate that at least 7 million children in the U.S. have attention-deficit/hyperactivity disorder (ADHD), diagnoses are also increasing in adults. According to 2024 data from healthcare technology company Truveta, first-time diagnoses for adults between the ages of 30 and 64 have grown significantly since 2021. When ADHD affects daily functions in adults, medication can be a helpful treatment tool, according to Yale Medicine experts—which is why a recent drug recall should be noted.

First reported by the U.S. Food and Drug Administration (FDA) on August 26, 2025, pharmaceutical company Lannett Company, LLC, voluntarily recalled 8,544 bottles of the medication Lisdexamfetamine Dimesylate due to a label mix-up. According to the FDA recall notice, “a bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.” The medication was distributed nationwide.

In a January 13 update, the FDA indicates that the recall is now “completed,” likely meaning that the recalling company has completed the actions it agreed to take.

Lisdexamfetamine Dimesylate belongs to a class of drugs known as central nervous system (CNS) stimulants and is used to treat ADHD symptoms in people ages 6 and older. It works by increasing attention and decreasing restlessness, according to the Mayo Clinic. It can also be used to treat moderate to severe binge eating disorder, and is sold under the brand names Arynta and Vyvanse in the United States. According to a product page on Lannett Company’s website, the company manufactures Lisdexamfetamine Dimesylate under the brand name Vyvanse.

The FDA notice provides the following details:

Lisdexamfetamine Dimesylate Capsules

40 milligrams (mg)
100-count bottles
Lot #: 25280726A
 Expiration Date: 03/2027
Rx Only
Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 0527-4664-37

As of August 25, 2025, the recall was designated a Class II event, meaning that exposure to the recalled product could cause reversible adverse health effects, though the probability of those effects is likely low.

ADHD is a neurodevelopmental disorder with symptoms beginning usually before the age of 12, according to the Cleveland Clinic. ADHD symptoms typically fall into two main subgroups: inattention (inability to focus on a task, getting distracted easily) and hyperactivity/impulsivity (inability to sit still or feel comfortable staying in one place, trouble waiting for your turn). Treatment is typically highly personal to the patient, and can involve psychotherapy, skills training, cognitive behavioral therapy, and/or medication.

For daily wellness updates, subscribe to The Healthy newsletter and follow The Healthy on Facebook and Instagram. Keep reading: