The Recall Desk
HighFDA (Drugs)·D-0810-2023·Announced 2023-06-07

Hydrocortisone and Acetic Acid Otic Solution Recalled Due to Manufacturing Deviations

Akorn, Inc. is recalling all lots of Hydrocortisone and Acetic Acid Otic Solution, USP (10 mL bottles) nationwide due to manufacturing deviations. The company ceased business and could not complete required stability studies to verify product quality.

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: FDA classified this as a Class II recall due to the potential for adverse health consequences from manufacturing deviations and inability to complete stability verification. No illnesses or injuries have been reported. The risk is theoretical but significant, as the manufacturer's inability to verify product stability constitutes a risk-of-harm situation per the rubric for products where injury has not yet been reported.

Plain-English summary

Akorn, Inc. is recalling all lots of Hydrocortisone and Acetic Acid Otic Solution, USP in 10 mL bottles distributed by Akorn, Inc., located in Gurnee, Illinois. The product is distributed nationwide in the USA and Puerto Rico.

The recall was issued due to Current Good Manufacturing Practice (CGMP) deviations. The manufacturer went out of business and was unable to continue the stability studies required to verify that the product maintains its safety and effectiveness throughout its intended shelf life.

No illnesses or injuries related to this product have been reported to date. Patients currently using this medication should consult their healthcare provider or pharmacist for guidance on the appropriateness of continued use and alternatives.

The recalled product

Product
Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Otic 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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Same hazard · cgmp deviation

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