RECALL DATABASE

Lisdexamfetamine Dimesylate Recall: Lannett 40 mg 100-count

Announced 2026-07-08 · FDA

FDA recall for Lisdexamfetamine Dimesylate capsules due to a labeling mix-up. A bottle labeled as 40 mg contained 30 mg. Nationwide distribution; Lot 25280726A, Exp 03/2027; 8,544 bottles affected.

BrandLannett Company Inc.
ProductLisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 0527-4664-37
ReasonLabeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
Severitymoderate
Units affected1392
DistributionNationwide within the USA
AgencyFDA

WHAT YOU SHOULD DO

  1. Check your bottle's lot number and expiration date: 25280726A, 03/2027.
  2. Do not use the product if the bottle labeled 40 mg contains 30 mg; consult your pharmacist or doctor for guidance.
  3. Return or dispose of the affected product per the manufacturer's or distributor's instructions; seek a replacement if offered.
  4. If you have questions, contact Lannett or the FDA for further guidance.

How to identify the recalled item

Lot / date codesLot #: 25280726A, Exp. Date 03/2027
Lot / date codesLot#: 25285401A, Exp. Date: 04/2027

These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.

This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.