The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1628-2020·Announced 2020-10-07

Akorn Recalls Eye Itch Relief Eye Drops Due to Manufacturing Deviations

Akorn, Inc. is voluntarily recalling 25,843 bottles of Eye Itch Relief eye drops due to CGMP deviations. The product was distributed nationwide in 14 states.

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: The recall is classified as FDA Class II, which typically involves a remote possibility of temporary or medically reversible health consequences. The source text does not report any illnesses or injuries, and the hazard is related to manufacturing deviations rather than a specific high-risk pathogen or structural defect.

Plain-English summary

Akorn, Inc. is voluntarily recalling 25,843 bottles of Eye Itch Relief, Ketotifen Fumarate Ophthalmic Solution 0.035%, Sterile, 5 mL. The recall was initiated on September 3, 2020, and was classified as Class II by the FDA. The reason for the recall is Current Good Manufacturing Practice (CGMP) deviations.

The affected product is identified by Lot 8A11A with an expiration date of 12/20. It was distributed by CVS Pharmacy, Inc. in Woonsocket, RI, and is identified by NDC 59779-920-01. The product was distributed nationwide in California, Indiana, Virginia, New Jersey, New York, Rhode Island, Florida, Texas, Missouri, Pennsylvania, Michigan, Alabama, Tennessee, and South Carolina.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions. The recall was terminated on August 1, 2022.

The recalled product

Product
Eye Itch Relief, Ketotifen Fumarate Ophthalmic Solution 0.035%, Sterile, 5 mL, Distributed by CVS Pharmacy, Inc. Woonsocket, RI 02895, NDC 59779-920-01
Manufacturer
Akorn, Inc.
Category
Drug — Ophthalmic Solution
Hazard
Affected units
25,843

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)

  • Lot 8A11A exp 12/20

Distribution

Distributed nationwide across the United States.

The notice also names 14 states specifically:

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