Drug Enforcement D-0599-2025

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

Status

Ongoing

Classification

Class II

Report Date

September 3, 2025

Termination Date

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Product Information

Product description
Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 0527-4664-37
Product quantity
8544 bottles
Reason for recall
Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide within the USA

Location & Firm

Recalling firm
Lannett Company Inc.
Address
1101 C Ave W

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0599-2025
Event ID
97397
Recall initiation date
August 11, 2025
Center classification date
August 25, 2025
Code info
Lot #: 25280726A, Exp. Date 03/2027
More code info
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