Sun Pharmaceutical Industries Inc: Xyvona (levorphanol Tartrate Tablets), 2mg, 100 Tablets
Xyvona Recall Summary Xyvona (levorphanol tartrate tablets), 2mg, is being recalled nationwide because the FDA denied approval to market the product under that brand name. The 100-tablet bottles were manufactured by Ohm Laboratories Inc. and distributed by Fort Bio-Pharma, LLC. This is a Class II recall affecting all U.S. states and the District of Columbia.
- 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/e47faa31-9bfa-4c10-a74e-a8c784c49949