Xyvona — Class II drug recall D-0599-2026
Ongoing recall by SUN PHARMACEUTICAL INDUSTRIES INC, reported 2026-06-10, distributed nationwide. Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketi
| Recall number | D-0599-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ, United States |
| Recall initiated | 2026-05-22 |
| Classified | 2026-06-18 |
| Reported by FDA | 2026-06-10 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| NDC | 72245-0058-10 |
| Lot numbers | AE11393 |
| Expiration dates | 2027-10 |
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
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0599-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.