SUN PHARMACEUTICAL INDUSTRIES INC recalls Xyvona 3mg tablets due to FDA denying marketing approval. This prescription drug was manufactured by Ohm Laboratories and distributed by Forte BioPharma.
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 has recalled Xyvona 3mg tablets because the FDA denied marketing approval for this prescription drug. This recall affects patients who have been prescribed this medication.
The FDA denied marketing approval for Xyvona, which means the product was not approved for sale in the United States. This recall was initiated because the product was not officially approved by the FDA, but it does not indicate an immediate safety hazard.
Prescription patients who have been prescribed Xyvona 3mg tablets are affected. Patients with legitimate prescriptions for this medication are most at risk.
Check for Xyvona 3mg tablets with NDC 72245-058-10, manufactured by Ohm Laboratories in New Brunswick, NJ, and distributed by Forte BioPharma in Las Vegas, NV. The recall covers specific lots produced by this manufacturer.
Verify if you have a valid prescription for Xyvona 3mg tablets from a healthcare provider.
The FDA denied marketing approval for Xyvona, so SUN PHARMACEUTICAL INDUSTRIES INC initiated this recall.
The recall is due to FDA denial of marketing approval, not an immediate safety hazard. No specific injury risks are mentioned.
Look for Xyvona 3mg tablets with NDC 72245-058-10, manufactured by Ohm Laboratories in New Brunswick, NJ, and distributed by Forte BioPharma in Las Vegas, NV.
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-0599-2026 — SUN PHARMACEUTICAL INDUSTRIES INC SUN PHARMACEUTICAL INDUSTRIES INC Hello, I own a SUN PHARMACEUTICAL INDUSTRIES INC that is covered by recall D-0599-2026 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.
