Lannett recalls extended-release amphetamine capsules over label mix-up, 1392 bottles
The capsules are labeled as extended-release (ER) but contain only immediate-release (IR) pellets, so the label does not match what is inside.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- 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.
- Company
- Lannett Company Inc.
- Hazard
- Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
- Units
- 1392 bottles
- Where sold
- US Nationwide.
- FDA classification
- Class II · Ongoing
- Classified by FDA
- July 2, 2026
- Recall started
- June 26, 2026
- FDA enforcement report
- July 8, 2026
- Identifiers
- Codes: Lot#: 25285401A, Exp. Date: 04/2027
- FDA recall number: D-0660-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- 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.
- Reason for recall
- Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
- Classification
- Class II (Ongoing)
- Distribution
- US Nationwide.
- Quantity
- 1392 bottles
Related recalls
Lannett recalls Niacin Extended-release Tablets, USP, 1,000 mg because they failed dissolution specifications
The recalled 90-count bottles of Niacin Extended-release Tablets, USP, 1,000 mg failed dissolution specifications, and the notice does not say what this could do to a person.
Lannett Company Inc. · 46,848 90-count bottles