# 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 — FDA Safety Label Change

> 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

**Manufacturer:** SUN PHARMACEUTICAL INDUSTRIES INC
**Date of action:** 20260610
**Canonical URL:** https://drugsmonitor.com/recall/c1723510-1a2a-408f-bf57-798a9d907851
**Last updated:** 2026-06-11

## Summary

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) — Safety Label Change on 20260610.

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

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*Educational recall record from DrugsMonitor.com. Confirm details with FDA primary sources.*