United StatesXyvona (levorphanol tartrate) tablets, 2 mg and 3 mg, 100-count Rx bottles labeled Forte BioPharma, manufactured by Ohm Laboratories and distributed by Fort Bio-Pharma (NDC 72245-762-10 for 2 mg; NDC 72245-058-10 for 3 mg), lots AD93852 (exp 06/2027) and AE11393 (exp 10/2027), sold nationwide in the United States, are affected. The products were recalled because the FDA denied marketing them under the proprietary name Xyvona for a labeling-related hazard.
What's being 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
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
Recalling firm: Sun Pharmaceutical Industries Inc, Princeton, NJ, United States.
How to identify it
Lot #: AD93852, Exp Date: 06/2027. Lot #: AE11393, Exp Date: 10/2027.
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
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide within the United States
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)