Sun Pharmaceutical Industries Inc: Xyvona (levorphanol Tartrate Tablets), 3mg, 100 Tablets
Recall Summary Sun Pharmaceutical is recalling Xyvona (levorphanol tartrate tablets), 3mg in 100-tablet bottles nationwide because the FDA denied approval for the product to be marketed under that name. The recall affects the specific product distributed by Fort Bio-Pharma, LLC with NDC number 72245-058-10, which was manufactured by Ohm Laboratories Inc. and distributed across all U.S. states and Washington, D.C.
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product
- 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
- 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/020a53a1-4e4a-4cde-9145-a5f7933871b6