The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0854-2023·Announced 2023-06-07

Valproic Acid Oral Solution Recalled for Manufacturing Compliance Deviation

Akorn, Inc. is recalling all lots of Valproic Acid Oral Solution, USP (250mg/5mL) nationwide. The recall was issued because the firm ceased operations and could not complete required stability studies as mandated by manufacturing regulations.

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 a prescription drug where required stability studies were not completed due to manufacturer closure. Although no illnesses or injuries have been reported, the inability to confirm ongoing safety and efficacy of the medication over its shelf life represents a risk-of-harm product where injury has not yet been reported, meeting the criterion for High severity.

Plain-English summary

Akorn, Inc. is recalling all lots of Valproic Acid Oral Solution, USP (250mg/5mL), distributed nationwide in the United States and Puerto Rico. The product is a prescription medication supplied in 473 mL bottles and distributed by Akorn Operating Company LLC, Gurnee, Illinois.

The recall was issued due to Current Good Manufacturing Practice (CGMP) deviations. The recalling firm ceased business operations and was unable to continue the stability studies required by federal manufacturing standards. Stability studies are essential to verify that a drug remains safe and effective throughout its shelf life.

This recall affects all patients who are currently using this product. All lots of the affected product are subject to recall.

Patients taking Valproic Acid Oral Solution should contact their pharmacy or healthcare provider regarding this recall and discuss next steps for their treatment.

The recalled product

Product
Valproic Acid Oral Solution, USP, 250mg/5mL, 473 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug
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.

See all →

Same hazard · cgmp deviation

See all →

Similar recalls