FDAFDA · Food and drugs·Recall number D-0599-2026
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
Published June 10, 2026 · Recall initiated: May 22, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Distributor
- Nationwide within the United States
- Lot
- Lot #: AE11393, Exp Date: 10/2027.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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