← FDA ENFORCEMENT
D-0599-2025Class II

Lannett Company Inc.

Recalling firm
Lannett Company Inc.
Product type
Drug
Status
Terminated
Report date
2025-09-03
Distribution
Nationwide within the USA
Firm state
IN
Product quantity
8544 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
Reason for recall

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

Product description

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

Code / lot info

Lot #: 25280726A, Exp. Date 03/2027

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.