Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Exten
Summary
The FDA issued a Class II for Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetami by Lannett Company Inc.. Reason: Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules..
Details
Source
Drug Recall
External ID
D-0660-2026
Action Date
2026-07-08
Status
Ongoing
Category
drug
Product 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.
Lot/Code Info: Lot#: 25285401A, Exp. Date: 04/2027
Quantity Affected: 1392 bottles
Reason for Recall
Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-26
Company
Seymour, IN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 39 drug recalls issued in the same week, part of 81 drug-related FDA actions this month.
Lannett Company Inc. has 10 FDA actions in our database, including 10 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Lannett Company Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Lannett Company Inc. have FDA actions?
Lannett Company Inc. has 10 FDA actions in our database, including 10 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0660-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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