Why it was recalled
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
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: AE11393, Exp Date: 10/2027.
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0599-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 22, 2026
- FDA report date
- Jun 10, 2026
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-0599-2026, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 99066
- Address
- 2 Independence Way
- Code information
- Lot #: AE11393, Exp Date: 10/2027.
- Postal code
- 08540-6620
- Report date
- Jun 10, 2026
- Product type
- Drugs
- Recall number
- D-0599-2026
- Classification
- Class II
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Reason for recall
- 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
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- May 22, 2026
- Initial firm notification
- Letter
- Center classification date
- Jun 18, 2026