The Recall Desk
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.

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 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
  • cgmp-deviation
  • unverified-stability

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.

Related recalls

Same category