The Recall Desk
ModerateFDA (Drugs)·D-0864-2023·Announced 2023-06-07

Tropicamide Ophthalmic Solution Recalled by Akorn for CGMP Deviations

Akorn Operating Company is recalling all lots of Tropicamide Ophthalmic Solution 0.1% nationwide due to Good Manufacturing Practice (CGMP) deviations. The firm ceased operations and could not complete required stability studies.

What this means for you

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 a Class II FDA recall without reported illnesses, injuries, or adverse events. The hazard stems from the firm's inability to complete required stability studies due to cessation of operations, which constitutes a precautionary regulatory compliance recall rather than evidence of actual product harm.

Plain-English summary

Akorn Operating Company LLC is recalling all lots of Tropicamide Ophthalmic Solution, USP 0.1%, in 15 mL bottles distributed nationwide and in Puerto Rico. The product is a prescription-only eye dilating solution.

The recall was initiated due to Good Manufacturing Practice (CGMP) deviations. The firm ceased operations and is unable to continue stability studies required to verify that the product meets quality standards.

This recall affects all lots and all National Drug Codes (NDCs) of this product. The distribution scope includes the United States nationwide and Puerto Rico. Patients or healthcare providers who have this product in stock should contact their pharmacist or healthcare provider for guidance.

Anyone who experiences adverse effects after using this product should report the event to the FDA's MedWatch program at 1-888-SAFEMEDS (1-888-723-3633) or online at www.fda.gov/medwatch.

The recalled product

Product
Tropicamide Ophthalmic Solution, USP 0.1%, 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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Same hazard · gmp deviation

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