Class II · ModerateActive recall
Xyvona (levorphanol tartrate tablets)
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot #: AE11393, Exp Date: 10/2027.
Where it was soldNationwide within the United States
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
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
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byOhm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Fort Bio-Pharma, LLC., Las Vegas, NV 89113
| Distributed by / for | Fort Bio-Pharma, LLC., Las Vegas, NV 89113 |
| NDC | 72245-058-10 |
Show the full FDA record
| Full product label | 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 |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC |
| Distribution | Nationwide within the United States |
| Recall initiated | 2026-05-22 |
| Report date | 2026-06-10 |
| Recall completed | — |
| Recall number | D-0599-2026 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Princeton NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.