The Recall Desk
HighFDA (Drugs)·D-0862-2023·Announced 2023-06-07

Pilocarpine Hydrochloride Ophthalmic Solution Recalled for Manufacturing Compliance Deviations

The FDA has recalled all lots of Pilocarpine Hydrochloride Ophthalmic Solution 4% due to manufacturing process deviations. The distributor ceased operations and cannot complete required stability testing.

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. Since no illnesses, injuries, or deaths are reported and the hazard is theoretical (inability to verify product stability), the score cannot exceed 3 per the rubric. This is scored as High (3) because the product represents a risk-of-harm where injury has not yet been reported—the incomplete stability studies mean the product's quality and safety cannot be verified over time.

Plain-English summary

The FDA has issued a Class II recall of Pilocarpine Hydrochloride Ophthalmic Solution, USP 4%, distributed in 15 mL bottles. All lots distributed nationwide in the United States and Puerto Rico are affected by this recall.

The recall was issued because Akorn, Inc., the manufacturing firm, went out of business. As a result, the firm could not continue Current Good Manufacturing Practice (CGMP) stability testing. Stability testing is necessary to verify the product maintains its strength, safety, and effectiveness throughout its shelf life.

Without completed stability testing, the FDA cannot verify that the product quality has been maintained over time. This is the reason all lots of this medication have been recalled.

The recalled product

Product
Pilocarpine Hydrochloride Ophthalmic Solution, USP 4%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug
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 · stability testing incomplete

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