Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only
Recalled by SUN PHARMACEUTICAL INDUSTRIES INC
Drug recall
SUN PHARMACEUTICAL INDUSTRIES INC
Class II — moderate
Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
SUN PHARMACEUTICAL INDUSTRIES INC has recalled Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on June 10, 2026 and was initiated on May 22, 2026. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.
What was recalled?
This recall covers Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only. The company behind the recall is SUN PHARMACEUTICAL INDUSTRIES INC, based in Princeton, NJ. The FDA describes the product as: “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”
Why was Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only recalled?
According to the FDA, the stated reason for the recall is: “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 should you do?
If you think you may have bought Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only, compare it against the product description and identifying codes (Lot #: AD93852, Exp Date: 06/2027.) before using it. This recall is currently listed as ongoing.
The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact SUN PHARMACEUTICAL INDUSTRIES INC or your local health authority.
About this recall
This recall was distributed in NJ. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.
Full recall details
- Status
- Ongoing
- Date reported
- June 10, 2026
- Recall started
- May 22, 2026
- Distributed in
- NJ
What you can do
Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.
Quick answers
Why was Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only recalled?+
According to the FDA: Labeling: Not Elsewhere Classified.
How serious is this recall?+
Class II — moderate. Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
What should I do if I have Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only?+
Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.
Opens the U.S. Food and Drug Administration (FDA) data for this recall.
Recall number: D-0598-2026. Information last synced from the FDA on July 6, 2026.