Xyvona 3 mg levorphanol tablets recalled after proprietary name denial
Xyvona levorphanol tartrate tablets, 3 mg, are being recalled following FDA's denial of marketing the product under the proprietary name Xyvona.
What this means for you
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), 3 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 72245-058-10, 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 AE11393, expiry 10/2027. 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), 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
- 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 #: AE11393
- Exp Date: 10/2027.
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.
See all 2 products in this recall →Related recalls
Same manufacturer · SUN PHARMACEUTICAL INDUSTRIES INC
See all →- HighSun Pharmaceutical Recalls Carbamazepine Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2026-08-26
- LowFexofenadine Hydrochloride Tablets 180 mg Recalled for Impurities
FDA (Drugs) · 2026-07-08
- HighPerampanel Prescription Tablets Recalled for Labeling Mix-up
FDA (Drugs) · 2026-07-01
- HighBudesonide inhalation ampules contain black and brown specks and particles
FDA (Drugs) · 2026-06-17
- SevereDoxorubicin liposome injection vials contain glass particulate matter
FDA (Drugs) · 2026-06-17
Same hazard · labeling issue
See all →- ModerateXyvona levorphanol tablets recalled after FDA denied the proprietary name
FDA (Drugs) · 2026-06-10
- HighGluten-Free Blueberry Bagels Recalled for Undeclared Egg Allergen
FDA (Food) · 2025-06-11
- ModerateKarl Storz Ureteroscope Recalled for Unapproved Reprocessing Instructions
FDA (Devices) · 2025-02-05
- HighBipolar Forceps Recall Due to Incomplete Instructions for Use
FDA (Devices) · 2022-12-14
- ModeratePalindrome RT Chronic Catheter Kit Labeling Enhancement Withdrawal
FDA (Devices) · 2021-09-08