FDAFDA recall D-0660-2026 · Jul 8, 2026
Lannett Company Inc.: Dextroamphetamine Saccharate recall
Recall found
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot#: 25285401A, Exp. Date: 04/2027
- Quantity
- 1392 bottles
- Distribution
- US Nationwide.
- Recalling firm
- Lannett Company Inc., Seymour, IN
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-06-26
Source: openFDA enforcement record D-0660-2026 · search recall number D-0660-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.