D-0598-2026 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- June 10, 2026
- Initiation Date
- May 22, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Fort Bio-Pharma, LLC., Las Vegas, NV 89113, NDC 72245-762-10
Reason for Recall
Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: AD93852, Exp Date: 06/2027.