FDAHealthMay 22, 2026

SUN PHARMACEUTICAL INDUSTRIES INC — Xyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by:

⚠️ 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 this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: May 22, 2026

Nationwide within the United States

What's affected?

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
Brand: SUN PHARMACEUTICAL INDUSTRIES INC
Lot code: AE11393

Additional details

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

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated

View original FDA notice →

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