Xyvona (levorphanol tartrate tablets) recall
FDA recall D-0599-2026 · initiated May 22, 2026
SUN PHARMACEUTICAL INDUSTRIES INC recalled Xyvona (levorphanol tartrate tablets) in May 2026 — an FDA Class II recall (D-0599-2026) because 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.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
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
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Details
- 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
- Recalling company
- Sun Pharm Industries
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- May 22, 2026
- FDA report date
- Jun 10, 2026
Frequently asked
- Was Xyvona (levorphanol tartrate tablets) recalled?
- SUN PHARMACEUTICAL INDUSTRIES INC recalled Xyvona (levorphanol tartrate tablets) in May 2026 — an FDA Class II recall (D-0599-2026) because 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. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Xyvona (levorphanol tartrate tablets) recalled?
- Per the FDA enforcement record, the reason for recall D-0599-2026 was: 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
- Is a recalled Xyvona (levorphanol tartrate tablets) dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Xyvona (levorphanol tartrate tablets) are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — Lot #: AE11393, Exp Date: 10/2027.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0599-2026.