May 2026 FDA Recall Drug by Sun Pharmaceutical Industries Inc
99066 - Labeling

This Not Yet Classified drug recall was voluntarily initiated by Sun Pharmaceutical Industries Inc on May 22, 2026 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number:

Reason for Recall
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
Initiated
05-22-2026
Reported
06-10-2026
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
99066
Classification About Classification
Relative degree of health hazard assigned by FDA.
Not Yet Classified
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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