The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0148-2023·Announced 2023-01-25

Ophthalmic solution recalled due to manufacturing quality control deviations

Akorn, Inc. is recalling 1,752 bottles of Olopatadine HCL Ophthalmic Solution, USP 0.1% nationwide due to manufacturing quality control deviations. Lot 1L03A with expiration 10/31/2023 is affected.

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: FDA Class II voluntary recall for CGMP deviations with no reported illnesses or injuries. The specific nature of the manufacturing deviation is not detailed in the source.

Plain-English summary

Akorn, Inc. is voluntarily recalling 1,752 bottles of Olopatadine HCL Ophthalmic Solution, USP 0.1%, an antihistamine and redness reliever eye drop. The recall was initiated on October 13, 2022, and reported to the FDA on January 25, 2023, due to manufacturing quality control deviations.

The affected product is Lot 1L03A with an expiration date of 10/31/2023 (NDC 17478-308-05), distributed nationwide. The FDA classified this as a Class II recall due to deviations from Current Good Manufacturing Practice (CGMP) standards. The recall is ongoing.

The recalled product

Product
Olopatadine HCL Ophthalmic Solution, USP 0.1%, Antihistamine and Redness Reliever, 5 mL (0.17 FL OZ) per bottle, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-308-05
Manufacturer
Akorn, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
1,752

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 (2)

  • Lot: 1L03A
  • EXP 10/31/2023

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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