Recall issued for ADHD drug… FDA warns of ‘adverse health risks’,
Millions of Americans who rely on medication to manage attention deficit hyperactivity disorder (ADHD) may be impacted by a new nationwide drug recall.
Sun Pharmaceutical Industries has issued a voluntary recall of several lots of lisdexamfetamine dimesylate capsules, a generic version of an ADHD treatment prescribed for patients aged six and older. It is commonly known as Vyvanse and Arynta.
The FDA classified the action as a Class II recall, meaning use of the product ‘may cause temporary or medically reversible adverse health consequences,’ though the risk of serious harm is considered remote.
According to the FDA, the recall was prompted by a failure in laboratory testing, as the affected lots of medication did not dissolve properly during quality control tests.
This defect could affect how the drug is absorbed in the body, potentially leading to patients receiving a lower dose than prescribed and reduced therapeutic effectiveness.
This could worsen ADHD symptoms and trigger fatigue or concentration problems.
Prescriptions for lisdexamfetamine dimesylate have risen substantially in the US over recent years.
Data shows that from 2012 to 2023, overall stimulant prescriptions grew by about 60 percent, and in 2023 lisdexamfetamine accounted for roughly 19 percent of all stimulant prescriptions.
In 2023 alone, more than nine million prescriptions were dispensed.
This increase coincides partly with a rise in ADHD diagnoses, especially among adults and women, as awareness and screening have improved.
The rise of telehealth services have also made it much easier for people to get ADHD evaluations and prescriptions.
The recall covers 100-count bottles of 10 mg to 70 mg capsules with expiration dates ranging from February 2026 to May 2026
The affected batches include 10 mg: AD42468 (exp. 2/28/2026); AD48705 (exp. 4/30/2026), 20 mg: AD42469 (exp. 2/28/2026), AD48707 (exp. 4/30/2026), 30 mg: AD42470 (exp. 2/28/2026), AD48708 (exp. 4/30/2026), 40 mg: AD48709 (exp. 4/30/2026), AD50894 (exp. 5/31/2026), 50 mg: AD48710 (exp. 4/30/2026), AD50895 (exp. 5/31/2026), 60 mg: AD48711 (exp. 4/30/2026), AD50896 (exp. 5/31/2026) and 70 mg: AD48712 (exp. 4/30/2026), AD50898 (exp. 5/31/2026).
The capsules were made by Sun’s manufacturing arm, Ohm Laboratories, which based in New Brunswick, New Jersey.
Patients who believe they may have medication from an affected lot are advised not to stop taking it without consulting a healthcare provider.
The FDA urges patients to contact their doctor or pharmacist for further guidance and to arrange for safe replacement if necessary.
For more information, patients can visit the FDA’s official recall page or contact Sun Pharmaceutical Industries directly.
Around 22 million Americans are estimated to have ADHD and just over half of these are prescribed medication to manage their symptoms, which can include impulsiveness, disorganization and difficulty focusing.
Medications are broadly classified into two main categories: stimulants and non-stimulants.
Stimulants, the most common type to treat ADHD, include methylphenidate and amphetamine-based medications, like lisdexamfetamine dimesylate, that improve the transmission of the brain chemical dopamine which affects mood, motivation and movement.
Non-stimulant options like atomoxetine, clonidine, and guanfacine can also be used, if stimulants are not effective or well tolerated.
These help improve the transmission of norepinephrine, a hormone that helps with alertness and focus.
Lisdexamfetamine dimesylate is a prodrug, meaning it becomes active only after being metabolized in the body into dextroamphetamine.
This design helps provide a smoother, longer-lasting effect and reduces the potential for misuse compared to some other stimulants.
Some of the best known brand names for ADHD medications include Adderall, Ritalin, Vyvanse, Focalin, Concerta, and Daytrana.
Exactly why the condition occurs is not completely understood, but ADHD tends to run in families, suggesting genes may play a part.
