← FDA ENFORCEMENT
D-0112-2025Class II

Lannett Company Inc.

Recalling firm
Lannett Company Inc.
Product type
Drug
Status
Terminated
Report date
2024-12-11
Distribution
Nationwide in the USA
Firm state
IN
Product quantity
1608 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.

Product description

Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA 19136, NDC: 0527-4661-37

Code / lot info

Lot: 23274856A, Exp 04/30/2025

Other recalls SPEQ maps to Validation & Qualification
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See all Validation & Qualification recalls →

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.