The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0839-2023·Announced 2023-06-07

Proparacaine HCl Ophthalmic Solution Recalled Due to Incomplete Stability Studies

Akorn, Inc. is recalling all lots of Proparacaine HCl Ophthalmic Solution 0.5% due to manufacturing deviations. The manufacturer could not complete required stability studies before going out of business.

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 for an ophthalmic medication with unverified stability due to incomplete manufacturing studies. While no illnesses or injuries have been reported, the inability to confirm medication stability represents a potential risk to users.

Plain-English summary

Akorn, Inc. is recalling all lots of Proparacaine HCl Ophthalmic Solution, USP 0.5%, 15 mL bottles (Rx only). The product was distributed nationwide in the USA and Puerto Rico.

The recall is due to Current Good Manufacturing Practice (CGMP) deviations. The manufacturer was unable to complete required stability studies because the company went out of business.

Stability studies are required to demonstrate that medications maintain their safety, purity, and potency throughout their labeled shelf life. Without completed stability data, the safety and efficacy of this ophthalmic solution cannot be fully confirmed.

The recalled product

Product
Proparacaine HCl 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
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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