The Recall Desk

FDA (Drugs) recall action 99066

SUN PHARMACEUTICAL INDUSTRIES INC recalled 2 products on 2026-06-10

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2026-06-10
Critical
0
Units
—

Why these products were 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

The agency’s own wording, quoted from the enforcement report.

1–2 of 2

  • ModerateFDA (Drugs)··2026-06-10

    Xyvona levorphanol tablets recalled after FDA denied the proprietary name

    Xyvona levorphanol tartrate tablets, 2 mg, are being recalled following FDA's denial of marketing the product under the proprietary name Xyvona.

    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
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2026-06-10

    Xyvona 3 mg levorphanol tablets recalled after proprietary name denial

    Xyvona levorphanol tartrate tablets, 3 mg, are being recalled following FDA's denial of marketing the product under the proprietary name Xyvona.

    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
    Category
    Distribution
    0 states