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Class II · ModerateRecall completed

Lisdexamfetamine Dimesylate

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: 25280726A, Exp. Date 03/2027
Where it was soldNationwide within the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byLannett Company, Inc.
Brand nameLISDEXAMFETAMINE DIMESYLATE
Generic nameLISDEXAMFETAMINE DIMESYLATE
Active ingredient(s)LISDEXAMFETAMINE DIMESYLATE
Distributed by / forLannett Company, Inc., Philadelphia, PA 19136
NDC0527-4664-37
Show the full FDA record
Full product labelLisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 0527-4664-37
Recalling firmLannett Company Inc.
DistributionNationwide within the USA
Quantity8544 bottles
Recall initiated2025-08-11
Report date2025-09-03
Recall completed2026-06-24
Recall numberD-0599-2025
ClassificationClass II
FDA statusTerminated
Origin on fileSeymour IN United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.