SUN PHARMACEUTICAL INDUSTRIES INC recalls Xyv: 2mg tablets due to FDA denying marketing under proprietary name Xyvona. No remedy specified in official notice.
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
SUN PHARMACEUTICAL INDUSTRIES INC is recalling Xyvona (levorphanol tartrate) 2mg tablets because the FDA denied approval to market them under this name. This recall does not involve a safety hazard but is a regulatory action.
The FDA denied marketing the product under the proprietary name Xyvona. This recall is a regulatory action, not a safety hazard. The product itself is safe but the company is not authorized to market it under this name.
Prescription patients who received Xyvona 2mg tablets from Forte BioPharma. Those with the specific NDC number 72245-762-10 are most affected.
Check for Xyvona 2mg tablets with NDC 72245-762-10, manufactured by Ohm Laboratories, distributed by Forte BioPharma. The recall covers specific lots from June 2027.
Verify the NDC number 72245-762-10 and lot number AD93852 on the packaging.
The FDA denied marketing the product under the proprietary name Xyvona, so SUN PHARMACEUTICAL INDUSTRIES INC initiated this recall.
No safety hazard is described; this is a regulatory action due to FDA denial of marketing.
The official notice does not specify a remedy, so check with your healthcare provider or pharmacy for guidance.
We’ve drafted a message you can send SUN PHARMACEUTICAL INDUSTRIES INC to request your refund or repair — edit it as you like.
Subject: Recall D-0598-2026 — SUN PHARMACEUTICAL INDUSTRIES INC SUN PHARMACEUTICAL INDUSTRIES INC Hello, I own a SUN PHARMACEUTICAL INDUSTRIES INC that is covered by recall D-0598-2026 from SUN PHARMACEUTICAL INDUSTRIES INC. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
