The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0832-2023·Announced 2023-06-07

FDA Recalls All Olopatadine HCl Nasal Spray Lots Due to Manufacturing Deviations

The FDA is recalling all lots of Olopatadine HCl Nasal Spray (665 mcg, manufactured by Akorn) nationwide and in Puerto Rico due to manufacturing quality deviations and incomplete stability studies.

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 3/5 (High).

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 FDA Class II recall involves CGMP deviations and the inability to complete required stability studies. While the source does not report any illnesses or injuries, the unverified stability of a prescription nasal spray represents a risk-of-harm situation where product safety cannot be confirmed.

Plain-English summary

The FDA is recalling all lots of Olopatadine HCl Nasal Spray, 665 mcg in 30.5 g bottles (Rx only), manufactured by Akorn, Inc. All National Drug Codes (NDCs) for this product are included in the recall.

The recall is due to Current Good Manufacturing Practice (CGMP) deviations. The manufacturer went out of business and could no longer continue the stability studies required to ensure product quality.

The product was distributed nationwide in the USA and Puerto Rico.

Patients currently using this medication should contact their healthcare provider to discuss their treatment and explore possible alternative options.

The recalled product

Product
Olopatadine HCl Nasal Spray, 665 mcg, 30.5 g bottles, Rx Only, Manufactured by: Akorn, Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Nasal Spray
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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