Drug Recall: Xyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Fort Bio-Pharma, LLC., Las Vegas, NV
SUN PHARMACEUTICAL INDUSTRIES INC · May 22, 2026
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
Product Description
Xyvona (levorphanol tartrate tablets), 3mg, 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 72245-058-10
Distribution
Nationwide within the United States
States Affected
NATIONWIDE
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0599-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.