Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate Capsule, Extended Release
FDA Recall NDC 0527-0790
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate (NDC 0527-0790). A significant event, classified as Class II, was initiated on Jun 26, 2026 by Lannett Company, Inc.. The reported reason for this action was: "Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
Jun 26, 2026
Jul 08, 2026
1392 bottles
Recall Profile & Regulatory Data
Event ID
99319
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Lannett Company Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide.
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.
Batch or Lot Expiration Information
Lot# : 25285401A, Exp. Date: 04/2027
Affected Packages Involved in this Recall
0527-0790-37Product
0527-0791-37Product
0527-0792-37Product
0527-0793-37Product
0527-0794-37Product
0527-0795-37Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
