CLASS II ONGOING Drug recall · Reported 10 Jun 2026 · FDA Enforcement Report

Xyvona (levorphanol tartrate tablets), 3mg recalled

SUN Pharmaceutical Industries is recalling Xyvona (levorphanol tartrate tablets), 3mg, distributed nationwide in the US. The recall was initiated on 22 May 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: AE11393, Exp Date: 10/2027.

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0599-2026
FDA event ID: 99066
Recalling firm: SUN Pharmaceutical Industries, Princeton, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 22 May 2026
FDA classified: 18 Jun 2026
Reported: 10 Jun 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons

Timeline

22 May 2026	Recall initiated by company
10 Jun 2026	Published in enforcement report	+19 days
18 Jun 2026	Classified by FDA	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Product as listed by the FDA

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

Where it was distributed

Nationwide within the United States

Nationwide

Questions about this recall

Why was it 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

Which lots are affected?

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

Where was it sold?

Nationwide within the United States

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 99066

This product is part of a recall event; the main page for the event is Xyvona (levorphanol tartrate tablets), 2mg recalled.

Reported	Class	Recall	Company	Reason	Where
10 Jun 2026	CLASS II	Xyvona (levorphanol tartrate tablets), 2mg recalled	SUN Pharmaceutical Industries	Other	Nationwide

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Other Xyvona (levorphanol recalls

All 2

Reported	Class	Recall	Company	Reason	Where
10 Jun 2026Drug	CLASS II	Xyvona (levorphanol tartrate tablets), 2mg recalled	SUN Pharmaceutical Industries	Other	Nationwide