ADHD Medication Recalled Due to Incorrect Labeling

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for combination extended-release capsules (5 mg) of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate. The affected batch has been identified as Lot 25285401A (expires April 2027), affecting 1392 bottles.
• The recall was initiated by Lannett Company, Inc due to a labeling mix-up, a quality issue that is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.
• This combination of drugs is used to treat attention deficit hyperactivity disorder (ADHD).

The FDA has issued a Class II recall for combination extended-release capsules (5 mg) of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate, affecting 1392 bottles. This product is being recalled by Lannett Company, Inc based in Seymour, Indiana. The recall was initiated on June 26, 2026, and received a Class II classification on July 2, 2026. A Class II classification means the use of this product is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.

The recall was initiated due to a labeling mix-up; the product is labeled as extended release but contains only immediate-release capsules. This deficiency affects Lot 25285401A, which will expire in April 2027. Lannett Company sent out a public notice via letter; no press release has been issued for this recall.

This prescription medication is used to treat children and adults with ADHD. Pharmacists should identify and quarantine Lot 25285401A, remove it from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. July 8, 2026. Accessed July 8, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=221274