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Lannett Company Inc.: Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules

DrugsSource: FDA (drug) · Date: 2026-07-08

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Lannett Company Inc.
Product
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.
Reason / hazard
Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide.
Recall initiated
2026-06-26
Code info
Lot#: 25285401A, Exp. Date: 04/2027
Product quantity
1392 bottles
Voluntary mandated
Voluntary: Firm initiated
City
Seymour
State
IN
Country
United States
Event id
99319
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