Xyvona recall (SUN PHARMACEUTICAL INDUSTRIES INC)
DrugClass IIOngoing
Summary: SUN PHARMACEUTICAL INDUSTRIES INC is recalling 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.
What is being recalled
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
Why
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
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Nationwide within the United States
How to tell if yours is affected
Lot #: AE11393, Exp Date: 10/2027.
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0599-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | May 22, 2026 |
| Reported | June 10, 2026 |
| Company | SUN PHARMACEUTICAL INDUSTRIES INC |
| Company location | Princeton, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
More recalls from SUN PHARMACEUTICAL INDUSTRIES INC · all drug recalls · recalls from May 2026