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Recall Observatory FDA recall evidence

Drug 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

D-0599-2026

May 22, 2026

Class II

Product summary

Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Event
Event 99066
Status
Ongoing
Classification
Class II
Quantity
Unavailable
Official record key
drug-enforcement:D-0599-2026

Official wording

Reason: 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

Code information: Lot #: AE11393, Exp Date: 10/2027.

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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