Xyvona levorphanol tablets recalled after FDA denied the proprietary name
Xyvona levorphanol tartrate tablets, 2 mg, are being recalled following FDA's denial of marketing the product under the proprietary name Xyvona.
The agency’s classification
FDA (Drugs): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall arising from a proprietary name approval issue with no defect described in the medicine itself, which fits the labeling band at Moderate.
Plain-English summary
Xyvona (levorphanol tartrate tablets), 2 mg, 100 tablets, from Forte BioPharma, manufactured by Ohm Laboratories Inc. of New Brunswick, New Jersey and distributed by Fort Bio-Pharma, LLC of Las Vegas, NDC 72245-762-10, is being recalled.
The stated reason is a labeling issue, not elsewhere classified: the recall was initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona. The FDA classified the action as Class II. The source does not describe any defect in the medicine itself.
The affected lot is AD93852, expiry 06/2027. Distribution was nationwide within the United States.
This is a prescription opioid analgesic. Patients should not stop a prescribed course without medical advice; anyone holding the affected lot should contact their pharmacy or prescriber.
The recalled product
- Product
- 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
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Opioid analgesic tablet
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: AD93852
- Exp Date: 06/2027.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by SUN PHARMACEUTICAL INDUSTRIES INC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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