← FDA ENFORCEMENT
D-0660-2026Class II

Lannett Company Inc.

Recalling firm
Lannett Company Inc.
Product type
Drug
Status
Ongoing
Report date
2026-07-08
Distribution
US Nationwide.
Firm state
IN
Product quantity
1392 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
Reason for recall

Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.

Product description

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules, 5 mg, Rx Only, 100 capsules, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC: 0527-0790-37.

Code / lot info

Lot#: 25285401A, Exp. Date: 04/2027

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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.