Nationwide Recall Issued for Generic Vyvanse Due to Efficacy Concerns
A nationwide recall has been issued for several lots of lisdexamfetamine dimesylate capsules, a generic version of the ADHD medication Vyvanse, because the medication may not release the full dose of medicine.
The Food and Drug Administration announced the recall on October 28, 2025, stating that the impacted capsules failed dissolution tests. According to the Board of Pharmacy, dissolution is critical for a drug to be absorbed and have the intended effect on the body. “Dissolution is important for drugs to be absorbed and have a physiological effect on the human body; they must be in solution,” the Board stated. “The impacted capsules would not be able to deliver an optimal level of medicine and may impact the therapeutic efficacy of the product.” This recall comes as ADHD diagnoses continue to rise, potentially impacting many individuals who rely on this medication.
While the medication is not considered a safety risk, officials say it may not be fully effective. The recall affects a wide range of dosages, including 10mg, 20mg, 30mg, 40mg, 50mg, 60mg, and 70mg pills. A complete list of affected lot codes can be found on the FDA website. Sun Pharmaceutical Industries, Inc. distributed the recalled medication between May 1, 2024, and November 13, 2024, despite a 2026 expiration date.
Patients who have the recalled medication are advised to contact their doctor or pharmacy for a replacement or refund. For more information on medication recalls, visit the FDA’s safety alerts page.
