The Recall Desk
HighFDA (Drugs)·D-0814-2023·Announced 2023-06-07

Akorn Lactulose Solution Recalled Due to Incomplete Stability Studies

Akorn, Inc. is recalling all lots of Lactulose Solution USP (Oral), 10g/15mL, distributed nationwide in the USA and Puerto Rico, due to the manufacturer's inability to complete required stability studies following company closure.

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: This FDA Class II recall involves a risk-of-harm product where no illnesses or injuries have been reported. The manufacturer's inability to complete stability studies prevents verification that the product meets quality standards, but the actual impact remains unconfirmed.

Plain-English summary

Akorn, Inc. is recalling all lots of Lactulose Solution, USP (Oral), 10g/15 mL, packaged in 15 mL, 30 mL, 473 mL, and 946 mL bottles. The affected product was distributed nationwide in the USA and Puerto Rico.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The manufacturer went out of business and was unable to continue the required stability studies for this product.

Stability studies are conducted to verify that medications maintain their intended safety, strength, and purity over their shelf life. The inability to complete these studies prevents confirmation that the product quality meets FDA standards.

The recalled product

Product
Lactulose Solution, USP (Oral), 10g/15 mL, packaged in a) 15mL bottles, b) 30 mL bottles, c) 473 mL bottles, and d) 946 mL bottles, 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 →

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