Why it was recalled
Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot#: 25285401A, Exp. Date: 04/2027
Where it was sold
US Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0660-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jun 26, 2026
- FDA report date
- Jul 8, 2026
- Quantity
- 1392 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lannett Company Inc.
Original FDA data
Every field from FDA enforcement report D-0660-2026, exactly as published.
Show all FDA fields
- City
- Seymour
- State
- IN
- Status
- Ongoing
- Country
- United States
- Event ID
- 99319
- Address
- 1101 C Ave W
- Code information
- Lot#: 25285401A, Exp. Date: 04/2027
- Postal code
- 47274-3342
- Report date
- Jul 8, 2026
- Product type
- Drugs
- Recall number
- D-0660-2026
- Classification
- Class II
- Recalling firm
- Lannett Company Inc.
- Product quantity
- 1392 bottles
- Reason for recall
- Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- US Nationwide.
- Recall initiation date
- Jun 26, 2026
- Initial firm notification
- Letter
- Center classification date
- Jul 2, 2026