The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0853-2023·Announced 2023-06-07

Akorn Tropicamide Ophthalmic Solution Recalled for Manufacturing Quality Deviations

Akorn recalls all lots of Tropicamide Ophthalmic Solution 0.5% (15 mL bottles) nationwide due to CGMP deviations. The firm was unable to complete required stability studies after ceasing operations.

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 3/5 (High).

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 is an FDA Class II recall involving CGMP deviations and incomplete stability studies, representing a risk-of-harm situation where product quality assurance could not be completed. No illnesses or injuries have been reported, but the inability to verify stability means the safety and efficacy profile remains uncertain.

Plain-English summary

Akorn Operating Company LLC is recalling all lots of Tropicamide Ophthalmic Solution, USP 0.5%, distributed in 15 mL bottles (Rx only). The recall affects products distributed nationwide in the United States and Puerto Rico.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The manufacturer went out of business and could no longer continue the stability studies required to ensure the product maintains its safety and efficacy throughout its labeled shelf life.

Tropicamide is a prescription eye drop used to dilate the pupil during diagnostic eye exams and certain ophthalmic procedures. Patients who possess this product should contact their prescribing eye care provider or pharmacist for guidance on safe alternatives or proper product disposition. Do not use the product without first consulting a healthcare provider.

The recalled product

Product
Tropicamide Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx 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 →

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