The Recall Desk
HighFDA (Drugs)·D-0784-2023·Announced 2023-06-07

FDA Recalls Apraclonidine Ophthalmic Solution Due to Manufacturing Compliance Failures

Akorn Inc. is recalling all lots of Apraclonidine Ophthalmic Solution 0.5% due to manufacturing compliance deviations. The firm went out of business and could not complete required stability studies.

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 prescription eye medication with unverified stability due to manufacturing process deviations. Although no illnesses or injuries have been reported, the product presents a theoretical risk of eye harm if the formulation becomes unstable, meeting the criterion for High severity.

Plain-English summary

Apraclonidine Ophthalmic Solution 0.5% is being recalled due to manufacturing compliance failures. The product is a prescription eye solution distributed nationwide in the United States and Puerto Rico, packaged in 5mL and 10mL bottles by Akorn Operating Company LLC.

Akorn, Inc., the manufacturer, encountered deviations from Good Manufacturing Practices (CGMP). Specifically, the firm went out of business and could no longer complete the required stability studies necessary to verify that the product would remain safe and effective throughout its shelf life. The FDA classified this recall as Class II. All lots are affected.

Patients currently using Apraclonidine Ophthalmic Solution 0.5% should contact their prescriber or pharmacist. The prescriber can recommend alternative treatments and advise on next steps for the patient's care.

The recalled product

Product
Apraclonidine Ophthalmic Solution 0.5%, packaged in a) 5mL and b) 10 mL bottles, Rx only, Sterile, For Topical Ophthalmic Use Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Ophthalmic 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 →

Related recalls

Same manufacturer · Akorn, Inc.

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Same hazard · cgmp violation

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