Dextroamphetamine Saccharate recall (Lannett Company Inc.)
DrugClass IIOngoing
Summary: Lannett Company Inc. is recalling 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: Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
What is being recalled
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.
Why
Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide.
How to tell if yours is affected
Lot#: 25285401A, Exp. Date: 04/2027
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0660-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | June 26, 2026 |
| Reported | July 8, 2026 |
| Company | Lannett Company Inc. |
| Company location | Seymour, IN, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 1392 bottles |
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