ADHD Medication Recalled Nationwide Over Potency Issues

A drug company has issued a nationwide recall of a type of drug used to treat attention deficit hyperactivity disorder (ADHD) due to potential potency concerns, according to notices released last week by the Food and Drug Administration (FDA).

Sun Pharmaceutical Industries initiated a recall of multiple lots of lisdexamfetamine dimesylate capsules on Oct. 28. The FDA on Oct. 30 determined that the recall is Class II. That means the product under recall could cause medically reversible or temporary adverse health consequences, although it is not likely to cause serious harm.

The reason for the recall, according to the FDA, is because of "failed dissolution specifications," which means the drug did not dissolve properly during testing. That could impact how it works in the body, says the FDA's website.

The Class II classification initiated by the FDA suggests there is "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 manufacturer, New Jersey-based Sun Pharmaceuticals, didn't issue a statement or news release about the drug recall, meaning there are no instructions for the users of the recalled medication.

Neither the FDA nor Sun Pharmaceuticals provided a list of how many lots or units of the drug are under recall.

List of Drugs Under Recall

In several FDA notices, the FDA listed lots of lisdexamfetamine dimesylate with different potencies and expiration dates.

• 10 mg with a lot number AD42468, an expiration date of Feb. 28,2026, or with the lot number of AD48705, and an expiration date of April 30, 2026
• 20 mg with a lot number of AD42469, an expiration date of Feb. 28,2026, or with the lot number of AD48707, and an expiration date of April 30, 2026
• 30 mg with a lot number of AD42470, an expiration date of Feb. 28,2026, or with the lot number of AD48708 , and an expiration date of April 30, 2026
• 40 mg with a lot number of AD48709, an expiration date of April 30, 2026, or with the lot number of AD50894, and an expiration date of May 31, 2026
• 50 mg with a lot number of AD48710, an expiration date of April 30, 2026, or with the lot number of AD50895, and an expiration date of May 31, 2026
• 60 mg with a lot number of AD48711, an expiration date of April 30, 2026, or with the lot number of AD50896, and an expiration date of May 31, 2026
• 70 mg with a lot number of AD48712 an expiration date of April 30, 2026, or with the lot number of AD50898, and an expiration date of May 31, 2026

Lisdexamfetamine dimesylate, which is sometimes sold under the brand name Vyvanse and Elvanse, is a prescription central nervous system stimulant that can be used to treat ADHD in children aged 6 and older and adults. It is also used to treat moderate to severe binge eating disorder in adults.

A database that tracks U.S. prescription statistics, ClinCalc, shows that more than 1.4 million people were prescribed the medication in 2023, with around 9.1 million prescriptions.

A notice about the recall was also posted by the California state Board of Pharmacy, which said that Sun Pharmaceuticals shipped out the products between May 1, 2024, and Nov. 13, 2024.

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