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Xyvona (levorphanol tartrate) 2mg Tablets
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DRUG RECALLMODERATE

Xyvona (levorphanol tartrate) 2mg Tablets

Forte BioPharma recalls Xyvona 2mg tablets over FDA name denial.

What to do

Check your prescription bottles for NDC 72245-762-10. Do not use the product; return it to the pharmacy or contact Forte BioPharma for a refund.

Posted
Updated
Recall No.
D-0598-2026
Agency
Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Recall ID
99066
Status
ONGOING

Why it was recalled

Forte BioPharma is recalling Xyvona (levorphanol tartrate tablets) 2mg, 100-count bottles due to FDA denial of marketing approval for the proprietary name Xyvona. The product was distributed nationwide.

Is mine affected?

Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.

ProductRecall #
Xyvona (levorphanol tartrate tablets), 2mg, 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 72245-762-10D-0598-2026
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 72245-058-10D-0599-2026

Where it was sold

Distributed nationwide.

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Editorial summary by Recall Canary · last updated 2026-07-28 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification