Sun Pharmaceutical Industries Inc: Xyvona (levorphanol Tartrate Tablets), 2mg, 100 Tablets
Recall Summary Xyvona (levorphanol tartrate tablets), 2mg, 100-tablet bottles are being recalled nationwide because the FDA denied approval for the product to be marketed under the brand name Xyvona. The recall affects batches distributed by Fort Bio-Pharma, LLC across all U.S. states and Washington, D.C. This is a Class II recall, meaning the product may cause adverse health effects, though the labeling issue does not involve safety problems with the medication itself.
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product
- 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
- 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
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-05-22
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide within the United States
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/b1200ff6-bccb-44d6-a479-bc7d6f8d2415