The Recall Desk
HighFDA (Drugs)·D-0861-2023·Announced 2023-06-07

Pilocarpine Hydrochloride Ophthalmic Solution Recall Due to Manufacturing Deviations

Akorn Inc. is recalling all lots of Pilocarpine Hydrochloride Ophthalmic Solution 2% due to manufacturing deviations that prevented completion of stability studies. The product was distributed nationwide in the USA and Puerto Rico.

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 is an FDA Class II recall where inability to complete stability studies prevents verification of drug safety and effectiveness over shelf life. This represents a risk-of-harm product where injury has not yet been reported, meeting the High severity criterion despite the absence of illnesses to date.

Plain-English summary

Akorn Inc. is recalling all lots of Pilocarpine Hydrochloride Ophthalmic Solution, USP 2%, distributed in 15 mL bottles through Akorn Operating Company LLC (Gurnee, IL 60031). The recall affects all National Drug Code (NDC) products.

The recall was initiated because Akorn went out of business and could no longer continue required stability studies. This resulted in Current Good Manufacturing Practice (CGMP) deviations that prevent verification of the product's safety and effectiveness over its shelf life.

The product was distributed nationwide in the USA and Puerto Rico. No illnesses or injuries have been reported in connection with this recall. Patients currently taking this medication should consult their healthcare provider about replacement options.

The recalled product

Product
Pilocarpine Hydrochloride Ophthalmic Solution, USP 2%, 15 mL bottles, Rx Only, Sterile, 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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