FDA Drugs recall ·

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate… recall

Recall number
D-0660-2026
Date
(initiated June 26, 2026)
Company / brand
Lannett Company Inc.
1101 C Ave W, Seymour, IN, United States
Category
Drugs › Class II
Classification
Class II
Status
Ongoing
Units affected
1392 bottles
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

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.

Why was it recalled?

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

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

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

Distribution

US Nationwide.

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (drugs), recall D-0660-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.