The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0801-2023·Announced 2023-06-07

Docusate Liquid Drug Recalled Over Incomplete Stability Testing

Akorn, Inc. is recalling all lots of DOCU LIQUID (docusate sodium) after the company ceased operations and could not complete mandatory stability testing required for FDA compliance.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The recall is precautionary, driven by the firm's inability to complete required stability studies due to closure, meeting the criterion for a voluntary precautionary recall.

Plain-English summary

Akorn, Inc. is recalling all lots of DOCU LIQUID (docusate sodium, 50 mg/5 mL) in 473 mL bottles and 10 mL unit dose cups distributed nationwide in the USA and Puerto Rico.

The recall was initiated because the firm went out of business and can no longer conduct stability studies required under Current Good Manufacturing Practices (CGMP). These studies are essential to demonstrate that the drug maintains its safety and efficacy throughout its shelf life. Without completion of these studies, there is no confirmation that the product remains safe and effective.

This recall affects all lots of this product that were distributed nationwide in the United States and Puerto Rico.

Consumers should stop using this product and contact their healthcare provider or pharmacist for advice on obtaining an alternative stool softener.

The recalled product

Product
DOCU LIQUID (docusate sodium, 50 mg/5 mL), packaged in 473mL bottles and b)10mL Unit Dose cups, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Stool Softener / Laxative
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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