The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0797-2023·Announced 2023-06-07

Akorn Recalls Cromolyn Sodium Ophthalmic Solution Over Stability Studies

Akorn Inc. is recalling all lots of Cromolyn Sodium Ophthalmic Solution, USP 4% due to manufacturing deviations. The firm went out of business and could no longer continue required stability studies.

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 precautionary and compliance-based, driven by the firm's inability to complete stability studies after business closure rather than a demonstrated safety defect or adverse event.

Plain-English summary

Akorn Inc. is recalling all lots of Cromolyn Sodium Ophthalmic Solution, USP 4% in 10 mL bottles due to Current Good Manufacturing Practice (CGMP) deviations. The firm went out of business and could no longer continue the stability studies required to demonstrate the product's safety and efficacy throughout its shelf life.

The recall affects all lots distributed nationwide in the United States and Puerto Rico. Patients currently using this medication should contact their healthcare provider to discuss alternative treatments and determine whether they should continue using their current supply.

The recalled product

Product
Cromolyn Sodium Ophthalmic Solution, USP, 4%, 10 mL bottles, Rx Only, 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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