The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0151-2023·Announced 2023-01-25

Prescription eye drop recall due to manufacturing compliance issues

Akorn, Inc. is recalling Olopatadine HCl Ophthalmic Solution due to manufacturing process deviations. The nationwide voluntary recall involves 121,176 bottles distributed across the United 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: This is a Class II FDA recall initiated voluntarily with no reported illnesses or injuries. The hazard involves manufacturing compliance deviations rather than a specific identified contamination or defect, which according to the severity rubric indicates low-risk or voluntary precautionary recalls.

Plain-English summary

Akorn, Inc. is recalling Olopatadine HCl Ophthalmic Solution USP 0.1% (an eye drop medication) in 5 mL bottles sold under NDC 60429-957-05. The product is marketed by GSMS, Incorporated and was distributed nationwide throughout the United States.

The recall was initiated because the manufacturing process did not comply with Current Good Manufacturing Practice (CGMP) requirements. This is classified as a Class II recall by the FDA. Akorn initiated this voluntary recall in October 2022, which was classified by the FDA center on January 13, 2023.

The affected products are identified by specific lot numbers: 1C61A with expiration date February 28, 2023; and lots 1D86A and 1D07A with expiration date March 31, 2023. A total of 121,176 bottles are affected.

If you have this medication, contact your pharmacist or healthcare provider to verify whether your bottle is affected based on the lot number and expiration date.

The recalled product

Product
Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC: 60429-957-05
Manufacturer
Akorn, Inc.
Category
Drug — Ophthalmic Solution
Hazard
Affected units
121,176

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 (5)

  • Lot: 1C61A
  • EXP 2/28/2023
  • 1D86A
  • 1D07A
  • EXP 3/31/2023

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 27 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 27 products in this recall →

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