FDA Drugs recall ·
Xyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx only… recall
- Recall number
- D-0599-2026
- Date
- (initiated May 22, 2026)
- Company / brand
- Sun Pharmaceutical Industries Inc
2 Independence Way, Princeton, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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 was it 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
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: AE11393, Exp Date: 10/2027.
Distribution
Nationwide within the United States
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0599-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.