FDA recall, , Moderate risk
Lannett Dextroamphetamine and Amphetamine Extended-Release Capsules
These capsules are labeled as extended-release but contain only immediate-release pellets.
Summary by Recall Canary from the FDA notice
What happened
Lannett Company Inc., of Seymour, Indiana, recalled 1392 bottles of 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, because the capsules contain only immediate-release (IR) pellets while labeled as ER capsules. The recall began on June 26, 2026, and was added to the FDA's Enforcement Report on July 2, 2026.
The product was distributed nationwide in the US.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
- NDC
- 0527-0790-37
- Lot code
- 25285401A
Recall details
- Company began the recall
- Sold in
US Nationwide.
- Company
- Lannett Company Inc.Seymour, Indiana
- Hazard
- Labeling error
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99319
- Recall number
- D-0660-2026
- Quantity recalled
- 1392 bottles
All recalls from Lannett Company Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
