Warning
SUN PHARMACEUTICAL INDUSTRIES INC Recalls Xyvona (levorphanol tartrate tablets)
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0599-2026Drug / Pharmaceutical
SUN PHARMACEUTICAL INDUSTRIES INC Recalls Xyvona (levorphanol tartrate tablets)
SUN PHARMACEUTICAL INDUSTRIES INC · Class II — Moderate Risk
Product Description
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
Reason for 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
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
Nationwide within the United States
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA classified this recall as Class II, indicating the pharmaceutical product may cause temporary health problems or poses a slight threat of a serious nature. SUN PHARMACEUTICAL INDUSTRIES INC initiated the recall on May 22, 2026. 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. The product was distributed nationwide. Consumers should check their purchases and discontinue use of any affected product. Contact SUN PHARMACEUTICAL INDUSTRIES INC for further instructions.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medication Defects.