Xyvona (levorphanol tartrate tablets) recall

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

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

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.

Company

SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ

Date

Wednesday, June 10

Severity

Class II
the product could cause temporary or reversible health problems.

Where sold

Nationwide
Nationwide within the United States

Status

Ongoing

Recall number

D-0599-2026

Source

U.S. Food and Drug Administration