FDA DrugsClass II
Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only, Forte BioPharm...
Published: June 10, 2026Recall ID: D-0598-2026Category: drugsCountry: US
Reason for Recall / Hazard
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
Product Description & Identification
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
Additional Source Details
| Field | Value |
|---|---|
| City | Princeton |
| State | NJ |
| Event id | 99066 |
| Address 1 | 2 Independence Way |
| Code info | Lot #: AD93852, Exp Date: 06/2027. |
| Postal code | 08540-6620 |
| Report date | 20260610 |
| Product type | Drugs |
| 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 |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260522 |
| Initial firm notification | Letter |
| Center classification date | 20260618 |
Overview
- Recalling FirmSUN PHARMACEUTICAL INDUSTRIES INC
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide within the United States