The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0844-2023·Announced 2023-06-07

Akorn Sodium Chloride Ophthalmic Ointment Recalled Due to Manufacturing Deviations

Akorn Inc. is recalling all lots of Sodium Chloride Ophthalmic Ointment 5% nationwide due to manufacturing practice deviations. The company ceased operations and could not continue stability studies required to verify the product's safety and effectiveness.

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: FDA Class II recall with no reported illnesses or injuries. The recall is based on manufacturing practice deviations and inability to complete required stability studies, making the hazard theoretical rather than confirmed, warranting a Moderate severity score per the rubric.

Plain-English summary

Akorn Inc., a pharmaceutical manufacturer located in Lake Forest, Illinois, is recalling all lots of Sodium Chloride Ophthalmic Ointment, USP 5% (3.5g tubes). The product was distributed nationwide throughout the United States and Puerto Rico.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, Akorn went out of business and consequently was unable to continue the stability studies mandated by FDA regulations. Stability studies are critical for demonstrating that pharmaceutical products remain safe and effective throughout their shelf life.

Without the ability to complete these required stability studies, the firm cannot provide assurance of the product's continued quality and performance. This lack of demonstrated stability led the FDA to classify this as a Class II recall.

The recalled product

Product
Sodium Chloride Ophthalmic Ointment, USP, 5%, 3.5g tubes, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Ophthalmic
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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