The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0834-2023·Announced 2023-06-07

Oxcarbazepine Oral Suspension Recalled Due to Manufacturing and Stability Deviations

Akorn Inc. is recalling all lots of Oxcarbazepine Oral Suspension 300 mg/5 mL due to manufacturing practice deviations. The firm went out of business and could not complete required stability studies.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving CGMP deviations and incomplete stability studies. While no illnesses or injuries have been reported, the inability to verify medication stability represents a potential risk to product quality and efficacy.

Plain-English summary

Akorn Inc. is recalling all lots of Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL in 250 mL bottles. The recall affects product distributed nationwide in the United States and Puerto Rico. Oxcarbazepine is an oral medication used for seizure control.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the recalling firm went out of business and could no longer complete the stability studies required under FDA regulations. These studies are essential to verify that the medication maintains its quality and potency throughout its labeled shelf life.

The recall includes all lots distributed across all National Drug Codes (NDCs) for this product formulation.

The recalled product

Product
Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Oral Suspension / Anticonvulsant
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All Lots

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 86 recalled by Akorn, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 86 products in this recall →

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