Class II U.S. Food and Drug Administration

Sun Pharmaceutical Industries Inc Xyvona , 3mg, 100 Tablets recall: Labeling: Not Elsewhere Classified. This recall has been initiated

Recall published 5 months ago

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 hazard: Drug safety concern

The product was withdrawn from distribution. Whether your own pack is affected comes down to the lot number.

What the notice says: 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

Why it matters: The FDA recorded an enforcement action against this product. The classification and the summary above describe how serious the agency considers it.

Recall details

Recall number
D-0599-2026
Published
June 10, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Sun Pharmaceutical Industries Inc
Product type
Prescription & OTC drugs
Distribution
Nationwide
Made in
United States
Lot / code info
Lot #: AE11393, Exp Date: 10/2027.

Products covered by this recall

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

Check your product

The notice names 5 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • AE11393

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 10
  • 2027

NDC number

On the carton and again on the bottle or blister label.

  • 72245-058-10

Package size

Match the net weight or the piece count on the front of the pack.

  • 3 mg

Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Drug safety

Sun Pharmaceutical Industries Inc — The product was withdrawn from distribution. Whether your own pack is affected comes down to the lot number.

  1. Check the lot number on your pack against the codes listed above.
  2. Ask the dispensing pharmacy for a replacement from an unaffected lot.
  3. Keep the carton; the lot number is often printed only on the outer pack.
  4. Report side effects you think the product caused to FDA MedWatch.

What the company owes you

A recalled medicine is the manufacturer’s cost to carry, not yours or your pharmacist’s.

  • The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
  • Ask the pharmacy to handle the claim where they can — they process recall returns in bulk and it saves you the correspondence.
  • Keep the carton, the leaflet and the pharmacy label together until the claim is closed.
  • Costs beyond the price of the medicine need to go to the company directly, in writing, with the recall number quoted.

Company contact: SUN PHARMACEUTICAL INDUSTRIES INC — 2 Independence Way, Princeton, NJ, 08540-6620

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Sun Pharmaceutical Industries Inc prescription & otc drugs 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 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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code AE11393; best-by date 10 or 2027. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Check the lot number on your pack against the codes listed above.

Can I get my money back?

The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.

Where was the recalled product sold?

It was distributed nationwide.

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