Sun Pharmaceutical Industries Inc: Xyvona (levorphanol Tartrate Tablets), 3mg, 100 Tablets
Recall Summary Sun Pharmaceutical is recalling Xyvona (levorphanol tartrate tablets), 3mg tablets nationwide because the FDA denied approval to market the product under the brand name "Xyvona." The recalled product was distributed across all U.S. states and was manufactured by Ohm Laboratories Inc. and distributed by Fort Bio-Pharma, LLC.
- 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/ebe729c7-852e-433b-a896-4305ad07420d