drugs MODERATE Updated 2026-06-10

SUN PHARMACEUTICAL INDUSTRIES INC recalls Xyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx

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Recalled 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

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Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #: AE11393, Exp Date: 10/2027.

✅ What Should You Do?

  1. 1Stop taking this medication and contact your doctor or pharmacist immediately.
  2. 2Do NOT flush medications down the drain — use an FDA-approved drug take-back program.
  3. 3Check the lot number on your bottle or packaging against the recalled lots listed above.
  4. 4Report adverse events to FDA MedWatch or call 1-800-FDA-1088.
View official government recall