FreshRecalls

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FDAClass II · Drug · Recalled July 8, 2026

Dextroamphetamine Saccharate recall — Lannett Company Inc.

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

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID
D-0660-2026
Brand
Lannett Company
Classification
Class II
Units affected
1392 bottles
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

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.

Affected products

Companies & origin

Recalling firm location
Seymour, IN, United States
Firm address
1101 C Ave W, N/A, 47274-3342

Identifying details (verbatim from the notice)

Product codes / lots
Lot#: 25285401A, Exp. Date: 04/2027
Distribution
US Nationwide.
Firm notified the public via
Letter
FDA event ID
99319
Recall initiated
June 26, 2026
FDA classified
July 2, 2026
FDA report date
July 8, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.

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