FreshRecalls

⚠ Data freshness notice: the most recent refresh of NHTSA was incomplete, so a very recent recall may be missing. Everything shown is accurate as of the last checked time on this page — for anything time-critical, confirm with the official sources linked below.

FDAClass II · Drug · Recalled June 10, 2026

Xyvona (levorphanol tartrate tablets) recall — SUN PHARMACEUTICAL INDUSTRIES INC

Hazard: 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

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID
D-0599-2026
Brand
SUN PHARMACEUTICAL INDUSTRIES
Classification
Class II
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Description

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

Affected products

Companies & origin

Recalling firm location
Princeton, NJ, United States
Firm address
2 Independence Way, 08540-6620

Identifying details (verbatim from the notice)

Product codes / lots
Lot #: AE11393, Exp Date: 10/2027.
Distribution
Nationwide within the United States
Firm notified the public via
Letter
FDA event ID
99066
Recall initiated
May 22, 2026
FDA classified
June 18, 2026
FDA report date
June 10, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.

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