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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…

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 Medicine & devices FDA June 10, 2026 Reached Texas
Read the official FDA notice →

What to do

Stop using the product and check it against the description above. Follow the remedy on the official notice; most recalls are refunded or replaced without a receipt. If you or a family member has already been affected, keep the packaging and the lot code — they're what a claim rests on later.

Details

Recalling company
SUN PHARMACEUTICAL INDUSTRIES INC — Princeton, NJ
Severity
Class II — moderate
Reported
June 10, 2026
Recall number
D-0599-2026
Status
Ongoing
Source
FDA

Where it went

Nationwide within the United States

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