Xyvona (levorphanol tartrate) 2mg Tablets
Forte BioPharma recalls Xyvona (levorphanol tartrate) 2mg tablets due to FDA denial of proprietary name.
Consumers should stop using the recalled product and return it to the place of purchase or contact Fort Bio-Pharma, LLC for instructions on disposal and refund.
Why it was recalled
Forte BioPharma is recalling Xyvona (levorphanol tartrate) 2mg tablets, 100-count bottles, because FDA denied marketing under the proprietary name Xyvona. The product is labeled Rx only and distributed by Fort Bio-Pharma, LLC.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
Xyvona (levorphanol tartrate tablets)
| Lot code | Strength | NDC / UPC | Recall # |
|---|---|---|---|
| AD93852, 2027 | 2 mg | NDC 72245-762-10 | D-0598-2026 |
| AE11393, 2027 | 3 mg | NDC 72245-058-10 | D-0599-2026 |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other recent recalls from SUN PHARMACEUTICAL INDUSTRIES INC
Editorial summary by Recall Canary · summary updated 2026-09-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification