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FDA · Drugs ·

Xyvona (levorphanol tartrate tablets) recall

SUN PHARMACEUTICAL INDUSTRIES INC recalled Xyvona (levorphanol tartrate tablets) on June 10, 2026 because of labeling: Not Elsewhere Classified. It was sold nationwide.

Why it was recalled

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's recalled

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 72245-762-10

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice