The Recall Desk
HighFDA (Drugs)·D-0805-2023·Announced 2023-06-07

FDA Recalls Akorn Gonak Eye Drops for Manufacturing Deviations

Akorn, Inc. recalled all lots of Gonak Hypromellose Ophthalmic Solution distributed in the USA and Puerto Rico after the firm ceased operations and could not complete required stability studies.

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 recall involves a risk-of-harm product (ophthalmic solution with incomplete stability studies) where no patient injuries or illnesses have been reported. Per the severity rubric, this classification corresponds to Score 3 / High.

Plain-English summary

Akorn, Inc. is recalling all lots of Gonak Hypromellose Ophthalmic Solution 25mg/mL in 15 mL bottles, distributed nationwide in the USA and Puerto Rico.

The recall was issued due to Current Good Manufacturing Practice (CGMP) deviations. The firm went out of business and could no longer continue the stability studies for the product.

The recalled product

Product
Gonak Hypromellose Ophthalmic Solution 25mg/mL, 15 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Ophthalmic
Hazard
  • manufacturing-deviation
  • stability-testing-incomplete

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.

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