Recalls / Class II
Class IID-0642-2025
Product
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.
- Brand name
- Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate
- Generic name
- Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate
- Active ingredients
- Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate
- Route
- Oral
- NDCs
- 0527-0760, 0527-0761, 0527-0762, 0527-0763, 0527-0764, 0527-0765, 0527-0766
- FDA application
- ANDA215565
- Affected lot / code info
- Lot#: 25283185A. Expiry: 02/28/2027
Why it was recalled
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.
Recalling firm
- Firm
- Lannett Company Inc.
- Manufacturer
- Lannett Company, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1101 C Ave W, N/A, Seymour, Indiana 47274-3342
Distribution
- Quantity
- 4,848 bottles
- Distribution pattern
- OH
Timeline
- Recall initiated
- 2025-08-19
- FDA classified
- 2025-09-11
- Posted by FDA
- 2025-09-17
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0642-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.