FDA recall D-0660-2026

Lannett Company Inc. · Class II · drug

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 for recall

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

Distribution

US Nationwide.

Key facts

Status
Ongoing
Initiation date
2026-06-26
Report date
2026-07-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Seymour, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0660-2026