RecallRadar
ModerateReported July 8, 2026 (6 days ago)

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate

Recalled by Lannett Company Inc.

Drug recall

Lannett Company Inc.

Class II — moderate

Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.

Lannett Company Inc. has recalled Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on July 8, 2026 and was initiated on June 26, 2026. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.

Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.

What was recalled?

This recall covers Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, with approximately 1392 bottles affected. The company behind the recall is Lannett Company Inc., based in Seymour, IN. The FDA describes the product as: “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 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate recalled?

According to the FDA, the stated reason for the recall is: “Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.”

What should you do?

If you think you may have bought Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, compare it against the product description and identifying codes (Lot#: 25285401A, Exp. Date: 04/2027) before using it. This recall is currently listed as ongoing.

The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Lannett Company Inc. or your local health authority.

About this recall

This recall was distributed in IN. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.

Full recall details

Status
Ongoing
Date reported
July 8, 2026
Recall started
June 26, 2026
Distributed in
IN
What was recalled
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 it was recalled (as stated by the FDA)
Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
How to identify the affected product
Lot#: 25285401A, Exp. Date: 04/2027
Amount recalled
1392 bottles

What you can do

Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.

Quick answers

Why was Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate recalled?+

According to the FDA: Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER…

How serious is this recall?+

Class II — moderate. Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.

What should I do if I have Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate?+

Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.

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View the official FDA record

Opens the U.S. Food and Drug Administration (FDA) data for this recall.

Recall number: D-0660-2026. Information last synced from the FDA on July 14, 2026.

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