FDA recall, , Moderate risk
Forte BioPharma Xyvona (Levorphanol Tartrate Tablets)
Xyvona (levorphanol tartrate tablets) has a labeling issue and is not marketed under the proprietary name.
Summary by Recall Canary from the FDA notice
What happened
SUN PHARMACEUTICAL INDUSTRIES INC, of Princeton, New Jersey, recalled Xyvona (levorphanol tartrate tablets) in 2mg and 3mg strengths, 100 Tablets, Rx only, distributed by Fort Bio-Pharma, LLC, of Las Vegas. The recall was initiated in response to the denial by the FDA of marketing the product under the proprietary name Xyvona. The recall began on May 22, 2026, and the product was distributed nationwide within the United States.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match your product and all the details in one listed combination.
An NDC (National Drug Code) is usually printed on the drug's label.
Xyvona (levorphanol tartrate tablets)
- Strength
- 2 mg
- NDC
- 72245-762-10
- Lot code
- AD93852
- Strength
- 3 mg
- NDC
- 72245-058-10
- Lot code
- AE11393
Recall details
- Company began the recall
- Sold in
Nationwide within the United States
- Company
- SUN PHARMACEUTICAL INDUSTRIES INCPrinceton, New Jersey
- Hazard
- Labeling error
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99066
- Recall numbers
- D-0598-2026 to D-0599-2026
All recalls from SUN PHARMACEUTICAL INDUSTRIES INC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report
Listed on Recall Canary
In FDA's weekly enforcement report
Classified by FDA
Summary updated
