Nearly 5,500 Bottles of Generic Vyvanse Have Been Recalled By the FDA
The recalled medication is used to support those with ADHD.
Published Aug. 27 2025, 2:27 p.m. ET
As medications used to treat ADHD have endured a years-long shortage, generic versions of popular ADHD medications have been prescribed with increasing frequency for patients in need. Yet, the efficacy and safety of these generic versions are not guaranteed, leading to unintended consequences, including being recalled by the U.S. Food and Drug Administration (FDA).
For a medication like Vyvanse, which is used to support those with ADHD, the generic version is under hot water with the FDA.
If you have been prescribed Vyvanse or its generic counterpart by your primary care physician, you should consult with them to ensure that your medication has not been recalled. It is imperative that the medication you take is safe, has not been recalled by the FDA, and that your intake of the medicine is being monitored by your doctor.
All of that said, keep reading below to learn more about the generic Vyvanse recall by the FDA and how many bottles have been impacted.

Generic Vyvanse has been recalled by the FDA.
According to the Enforcement Report on the FDA website, 5,448 bottles of Lisdexamfetamine Dimesylate capsules that were manufactured by OHM Laboratories and distributed by Sun Pharmaceuticals, Inc., have been recalled since June 16.
Both the manufacturer and distributor are based in New Jersey. The reason for the recall, per the FDA website: "Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station."
The FDA escalated the concern to a Class II recall on July 11. Per the FDA, such a classification indicates that "use of, or exposure to, the product may cause temporary or medically reversible adverse health consequences, or an outcome where the probability of serious adverse health consequences is remote."
According to the Mayo Clinic website, "Lisdexamfetamine Dimesylate is used to treat attention deficit hyperactivity disorder (ADHD) in adults and children 6 years of age and older. This medicine is also used to treat moderate to severe binge eating disorder (BED). It belongs to the group of medicines called central nervous system (CNS) stimulants."
The medication, per the Mayo Clinic website, is only available with a doctor's prescription.
In September 2024, it was reported that drugmakers were given the green light to "increase production" of ADHD medications — specifically, both Vyvanse and its generic counterpart — by almost 25%.
"ADHD drugs have been in short supply for years," per the report, and as delays in manufacturing and supply occurred, demand has only increased for Vyvanse and its generic version.
“These adjustments are necessary to ensure that the United States has an adequate and uninterrupted supply of lisdexamfetamine to meet legitimate patient needs both domestically and globally,” the U.S. Drug Enforcement Administration (DEA) said at the time.
Today, it appears that the significantly increased production has invited new, unforeseen issues in the quality assurance realm during the manufacturing of the generic version of Vyvanse.
Consult your doctor if you believe you may have a generic version of Vyvanse that has been recalled. It is important to discuss with your doctor if there may need to be an alternative medication prescribed for your safety.