The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0833-2023·Announced 2023-06-07

Olopatadine HCl Eye Drops Recalled for Manufacturing Quality Deviations

Akorn, Inc. is recalling all lots of Olopatadine HCl Ophthalmic Solution, USP 0.1% eye drops due to Current Good Manufacturing Practice deviations. The manufacturer discontinued 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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is FDA Class II without reported illnesses, injuries, or deaths. The hazard is incomplete manufacturing process validation and unfinished stability testing—a precautionary concern rather than an active, reported harm. Per the rubric, this scores Moderate (2).

Plain-English summary

Akorn, Inc. is recalling all lots of Olopatadine HCl Ophthalmic Solution, USP 0.1%, supplied in 5 mL bottles. The recall affects all National Drug Codes (NDCs) for this product and applies nationwide in the United States and Puerto Rico.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The manufacturer could no longer continue required stability studies after going out of business. Stability studies verify that the medication maintains its safety and efficacy throughout its shelf life. Without completion of these studies, the integrity and reliability of the product cannot be assured.

Patients currently using this medication should contact their healthcare provider or pharmacist for guidance on whether continued use is appropriate and what alternatives may be available. Healthcare providers should review their inventory of this product and consult FDA guidance for appropriate handling and disposition.

The recalled product

Product
Olopatadine HCl Ophthalmic Solution, USP, 0.1%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. 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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