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FDAMay 22, 2026drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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 to do

FDA enforcement status: Ongoing

Brands named

sun pharmaceuticalsun

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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