ADHD drug may not dissolve correctly

Millions of Americans who rely on medication for attention deficit hyperactivity disorder (ADHD) may be affected by a new drug recall.

Sun Pharmaceutical Industries has issued a voluntary, nationwide recall for several lots of lisdexamfetamine dimesylate capsules, a generic version of an ADHD treatment prescribed for people over age 6.

The U.S. Food and Drug Administration (FDA) classified the recall as a Class II risk. This indicates that using the product “may cause temporary or medically reversible adverse health consequences,” but the probability of serious harm is considered remote.

The reason for the recall is a failure in laboratory testing. The FDA said the affected lots of medication did not dissolve as expected during tests.

This problem could affect how well the drug works in the body, potentially resulting in patients not getting the intended dose and the full therapeutic benefit.

Lisdexamfetamine dimesylate is a widely used drug, with data showing that over nine million prescriptions were dispensed in 2023, according to Newsweek.

The recall covers 100-count bottles across a range of doses.

The affected lot numbers and expiration dates are:

• 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)
• 70 mg: AD48712 (exp. 4/30/2026), AD50898 (exp. 5/31/2026)

The FDA recommends patients contact their health care provider before stopping any medication abruptly and seek additional guidance.

More information

For a full list of recalled products and additional details, visit the U.S. Food and Drug Administration’s enforcement reports page.

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