The Recall Desk
ModerateFDA (Drugs)·D-0781-2023·Announced 2023-06-07

Acetic Acid Otic Solution recalled due to manufacturing deviations and unverified stability

Akorn is recalling all lots of Acetic Acid Otic Solution nationwide due to manufacturing practice deviations. The firm went out of business and could not complete stability studies required to verify the product remained safe and effective.

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 recall with no reported illnesses or adverse effects. The recall is driven by manufacturing compliance deviations and incomplete stability verification, representing a precautionary measure rather than documented product harm.

Plain-English summary

Akorn Operating Company LLC is recalling all lots of Acetic Acid Otic Solution nationwide, including Puerto Rico. The product is a prescription ear medication supplied in 15 mL bottles under multiple national drug codes (NDCs).

The recall was initiated due to current good manufacturing practice (CGMP) deviations. The manufacturing firm went out of business and was unable to continue and complete required stability studies. These studies are essential to confirm that the product maintains its safety and effectiveness throughout its intended shelf life.

Patients currently using this medication should consult their healthcare provider or pharmacist before stopping treatment or using remaining doses. Healthcare providers should consider alternative treatments for their patients.

Consumers and healthcare providers with questions or who believe they have experienced adverse effects related to this product should report them to the FDA MedWatch program.

The recalled product

Product
Acetic Acid Otic Solution, 15 mL per bottle, Rx only, 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 · manufacturing deviation

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