The Recall Desk
HighFDA (Drugs)·D-0816-2023·Announced 2023-06-07

Levetiracetam Oral Solution Recalled Nationwide for Incomplete Stability Testing

Akorn, Inc. is recalling Levetiracetam Oral Solution nationwide after closing and failing to complete required FDA stability studies. The Class II recall affects all lots distributed in the United States and Puerto Rico.

What this means for you

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: FDA Class II recall for a pharmaceutical product where required stability studies could not be completed due to firm closure. Incomplete stability testing represents a risk-of-harm product where safety and efficacy cannot be verified. Per the rubric, theoretical hazards without reported injury qualify as High severity.

Plain-English summary

Akorn, Inc. is recalling Levetiracetam Oral Solution 100 mg/mL (473 mL bottles, all lots) distributed nationwide in the United States and Puerto Rico. The product is distributed by Akorn, Inc., Gurnee, Illinois.

The recall was initiated due to CGMP deviations. The company went out of business and could no longer continue the stability studies required by the FDA to ensure pharmaceutical products remain safe and effective throughout their shelf life.

Patients taking this medication should consult their healthcare provider about obtaining an alternative supply. Healthcare providers and pharmacies should immediately quarantine remaining stock and contact their suppliers for return instructions.

The recalled product

Product
Levetiracetam Oral Solution 100 mg/mL (100 mg/mL), 473 mL, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Oral Solution
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 →

Related recalls

Same manufacturer · Akorn, Inc.

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Same hazard · cgmp violation

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