The Recall Desk
HighFDA (Drugs)·D-0598-2026·Announced 2026-06-10

[pending] Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by:

Pending LLM rewrite. Source: FDA_DRUG D-0598-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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

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

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.