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Saturday, November 08, 2025
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US issues nationwide recall of ADHD drug over failed quality tests

publish time

08/11/2025

publish time

08/11/2025

US issues nationwide recall of ADHD drug over failed quality tests
Bottles of ADHD medication were recalled in the US after failing quality tests, the FDA said.

WASHINGTON, Nov 8: Several lots of a prescription medication used to treat Attention Deficit Hyperactivity Disorder (ADHD) have been recalled nationwide after failing laboratory tests, according to the latest U.S. Food and Drug Administration (FDA) Enforcement Reports.

The recall involves multiple batches of Lisdexamfetamine Dimesylate capsules — a generic version of the widely prescribed ADHD drug Vyvanse — manufactured by Sun Pharmaceutical Industries Inc. The recall was issued on October 28, and the FDA classified it as a Class II recall on October 30, indicating that while the use of the affected product may cause temporary health consequences, the likelihood of serious adverse effects is remote.

The recall was prompted by “Failed Dissolution Specifications,” meaning the capsules did not dissolve properly during quality testing. Improper dissolution can affect how the medication is absorbed and how effectively it works in the body.

This recall follows a similar issue reported last month that led to the withdrawal of more than 140,000 bottles of a popular cholesterol medication due to the same defect.

“These recalls are generally conducted at the retail level, and patients and consumers can continue using the medicine unless otherwise directed by the recalling company or FDA,” the agency’s classification notice stated.

No formal press release has been issued regarding the recall, and no specific instructions have been provided to consumers. However, health experts caution that stopping ADHD medication abruptly is not recommended as it may cause withdrawal symptoms.

Patients who possess any of the affected bottles are advised to consult their pharmacist or healthcare provider for guidance on next steps.