Status
Ongoing
Drug Enforcement D-0642-2025
Presence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100ct, contained one (1) tablet of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 5 mg.
Classification
Class II
Report Date
September 17, 2025
Termination Date
—
Product Information
- Product description
- Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100 Tablets per bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-0762-37.
- Product quantity
- 4,848 bottles
- Reason for recall
- Presence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100ct, contained one (1) tablet of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 5 mg.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- OH
Location & Firm
- Recalling firm
- Lannett Company Inc.
- Address
-
1101 C Ave W, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0642-2025
- Event ID
- 97461
- Recall initiation date
- August 19, 2025
- Center classification date
- September 11, 2025
- Code info
- Lot#: 25283185A. Expiry: 02/28/2027
- More code info
- —