Xyvona (Levorphanol) 2mg Tablet Recall: FDA Denial of Marketing
Sun Pharmaceutical recalls Xyvona 2mg tablets due to FDA denial of marketing under the proprietary name. Check lot AD93852.
Recall notice
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
Contact the company
What happened, in plain English
Sun Pharmaceutical Industries Inc. is recalling Xyvona (levorphanol tartrate) 2mg tablets because the FDA denied marketing the product under that proprietary name. The affected batch was distributed nationwide and expires in June 2027. No physical defect or injury risk is described, only a regulatory labeling issue. Read more at govinfonow.com/recall/31289-xyvona-levorphanol-2mg-tablet-recall-fda-denial-of-marketing.
Source Summary by GovInfoNow · govinfonow.com/recall/31289-xyvona-levorphanol-2mg-tablet-recall-fda-denial-of-marketing · Updated October 9, 2026 · FDA enforcement record: FDA #D-0598-2026
Cite this page
“Xyvona (Levorphanol) 2mg Tablet Recall: FDA Denial of Marketing.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/31289-xyvona-levorphanol-2mg-tablet-recall-fda-denial-of-marketing. Based on FDA recall #D-0598-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0598-2026%22&limit=1).
Why it’s dangerous
The recall is based on a regulatory violation where the FDA denied marketing the product under the proprietary name Xyvona. The record does not describe any physical danger, contamination, or mechanism of injury associated with the tablets themselves.
Who’s affected
Patients who have been prescribed Xyvona (levorphanol tartrate) 2mg tablets by their healthcare provider. Specifically, those who possess the batch with Lot # AD93852.
How to tell if you have this one
Look for Xyvona (levorphanol tartrate) tablets, 2mg strength, in a 100-tablet Rx-only bottle. Check for NDC 72245-762-10 and Lot # AD93852 with an expiration date of 06/2027. The product is manufactured by Ohm Laboratories Inc. and distributed by Fort Bio-Pharma, LLC.
- Brand
Xyvona- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Nationwide within the United States
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0598-2026 | 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; Lot #: AD93852, Exp Date: 06/2027. | — |
| D-0599-2026 | 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; Lot #: AE11393, Exp Date: 10/2027. | — |
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 19 days after the firm started it.
- Firm started the recall
- Published in FDA’s Enforcement Report
- FDA classified it Class II
Dates from the agency record only; steps without a date are left out.
Questions people ask
What lot numbers are affected?
Only Lot # AD93852 is listed in this record as part of the recall.
Similar recalls
Other Xyvona recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0598-2026 (May 22, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0598-2026 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.