FDA-Drug2026-07-08Class IIMISBRANDING
Lannett amphetamine extended-release capsules recalled for incorrect labeling
What this means
Lannett Company distributed amphetamine extended-release capsules that contained only immediate-release pellets but were labeled as extended-release. This labeling error could result in incorrect dosing and medication timing for patients who depend on the extended-release formulation.
- If you have this medication (NDC 0527-0790-37, Lot# 25285401A, expiration 04/2027), contact your pharmacist or doctor.
- Do not stop taking your medication without talking to your healthcare provider first.
- Your pharmacy can verify whether your bottle is affected and provide a replacement if needed.
The agency's original wording
Hazard
Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide.
Affected count
1392 bottles
Manufactured in
1101 C Ave W, N/A, Seymour, IN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0660-2026Want us to check the next one for you?
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