A voluntary, nationwide recall of Lisdexamfetamine dimesylate capsules, a drug often used to treat Attention Deficit Hyperactivity Disorder (ADHD) in adults and children over 6, has been issued by the pharmaceutical company, Sun Pharmaceutical Industries, with the U.S. Food and Drug Administration (FDA) classifying the recall as a Class II risk.
Newsweek has contacted Sun Pharmaceutical Industries via email outside of regular office hours.
Why It Matters
This recall could potentially affect millions of people across America, as Lisdexamfetamine dimesylate is one of the most commonly prescribed medications for ADHD in the United States, data indicating that over 9 million prescriptions of the drug were dispensed in 2023.
What To Know
Sun Pharmaceutical Industries initiated a voluntary recall of several lots of lisdexamfetamine dimesylate capsules on October 28, which was then given a Class II risk level by the FDA on October, 30, meaning it could cause “temporary or medically reversible adverse health consequences,” but it’s not likely to cause serious harm.
The FDA announced that the medication “failed dissolution specifications,” which means it didn’t dissolve as expected during laboratory tests, which could affect how well it works in the body.
The nationwide recall applies to the following lots, which were distributed in 100-count bottles:
10 mg: Lot numbers AD42468 (exp. 2/28/2026), AD48705 (exp. 4/30/2026)20 mg: Lot numbers AD42469 (exp. 2/28/2026), AD48707 (exp. 4/30/2026)30 mg: Lot numbers AD42470 (exp. 2/28/2026), AD48708 (exp. 4/30/2026)40 mg: Lot numbers AD48709 (exp. 4/30/2026), AD50894 (exp. 5/31/2026)50 mg: Lot numbers AD48710 (exp. 4/30/2026), AD50895 (exp. 5/31/2026)60 mg: Lot numbers AD48711 (exp. 4/30/2026), AD50896 (exp. 5/31/2026)70 mg: Lot numbers AD48712 (exp. 4/30/2026), AD50898 (exp. 5/31/2026)
Sun Pharmaceutical Industries hasn’t issued an official press release or advice about what to do if someone has the potentially defective drug. Generally, medical experts advise patients not to stop taking this type of medication immediately, as this might cause adverse withdrawal symptoms. However, if they have one of the aforementioned prescription bottles, they should cease taking them, according to health.com, and immediately contact their healthcare provider or pharmacy for guidance on getting a replacement or refund.
What People Are Saying
The FDA states that a Class II is issued when: “A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
The American Academy of Family Physicians (AAFP) says: “It is generally not recommended to stop taking a stimulant medication ‘cold turkey,’ or suddenly, which may cause uncomfortable withdrawal symptoms. Instead, a slow and controlled taper, or weaning-off period, under medical supervision is considered more desirable.”
What Happens Next
Patients who find that their medication is part of the recall are strongly advised to contact their healthcare provider or pharmacy for further instructions.