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Drug FDA Class II Completed Mislabeling

Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 0527-4664-37

Lannett Company Inc. Published Sep 3, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 55/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Lannett Company Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Affected products (1)

Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 0527-4664-37

LISDEXAMFETAMINE DIMESYLATE · 8544 bottles

NDC: 0527-4661, 0527-4662, 0527-4663, 0527-4664, 0527-4665, 0527-4666, 0527-4667, 0527-4661-37, 0527-4662-37, 0527-4663-37, 0527-4664-37, 0527-4665-37, 0527-4666-37, 0527-4667-37
Code info: Lot #: 25280726A, Exp. Date 03/2027

Affected areas

Nationwide

Timeline

  1. Initiated
    Aug 11, 2025
  2. Published
    Sep 3, 2025
Recall number
D-0599-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.