The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0779-2023·Announced 2023-06-07

Akorn Atropine Sulfate Eye Drops Recalled Due to Manufacturing Compliance Failures

Akorn, Inc. is recalling all lots of Atropine Sulfate Ophthalmic Solution USP 1% because the firm went out of business and could not complete required stability studies. The product was distributed nationwide in the USA and Puerto Rico.

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, injuries, or deaths. The recall is precautionary due to the manufacturer's inability to complete required stability studies; no evidence of actual product contamination or defect is cited in the source.

Plain-English summary

Akorn, Inc. is recalling all lots of Atropine Sulfate Ophthalmic Solution USP 1% (an eye drop medication) packaged in 2 mL, 5 mL, and 15 mL bottles distributed by Akorn Operating Company LLC. The product was distributed nationwide in the USA and Puerto Rico.

The firm initiated this recall because it went out of business and could no longer continue the stability studies required by U.S. Food and Drug Administration regulations. These studies are essential to confirm that the product remains safe, effective, and stable under various storage conditions throughout its shelf life.

Patients currently using this product should consult their prescribing physician or pharmacist about alternative treatments. Healthcare providers should contact Akorn or their distributors to identify affected lots. Unused product should not be discarded in trash or flushed down drains; consumers should contact their pharmacist or local hazardous waste facility for proper disposal.

The recalled product

Product
Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, packaged in a) 2 mL bottles b) 5 mL bottles, and C) 15 mL bottles, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Ophthalmic / Eye Drops
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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