The Recall Desk
ModerateFDA (Drugs)·D-0628-2022·Announced 2022-03-02

Nasal Spray Oxymetazoline HCl Recalled Due to Contaminated Excipient

Perrigo Company PLC is recalling Nasal Maximum Strength Nasal Spray (Oxymetazoline HCl 0.05%) due to contamination from a recalled excipient used during manufacturing. Approximately 2,302 bottles were distributed nationwide.

What this means for you

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 FDA classified this as a Class II recall. The source text does not report any illnesses, injuries, or deaths, and the hazard is related to a manufacturing deviation (contaminated excipient) without explicit statement of the nature or severity of potential harm. Per the rubric, Class II recalls without reported hospitalization typically fall to Moderate (score 2).

Plain-English summary

Perrigo Company PLC is recalling Nasal Maximum Strength Nasal Spray containing Oxymetazoline Hydrochloride 0.05% (1 FL Oz / 30 mL bottles, NDC 41250-989-10). The recall was initiated because the products were manufactured using a contaminated excipient that was itself recalled by the excipient supplier.

The affected batch is 1BK0716 with an expiration date of 12/31/2022. Approximately 2,302 bottles were distributed nationwide in the USA and were distributed by Meijer Distribution, Inc., Grand Rapids, MI.

The FDA has classified this as a Class II recall. Consumers who have purchased this product should stop use and consult their healthcare provider if they have any concerns about their health. Consumers with questions may contact Perrigo Company PLC or their pharmacy.

The recalled product

Product
NASAL (OXYMETAZOLINE HYDROCHLORIDE)
Brand
NASAL
Manufacturer
Perrigo Company PLC
Hazard
  • contamination
  • manufacturing-deviation

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)

  • Batch: 1BK0716
  • Exp 12/31/2022

Distribution

Distributed nationwide across the United States.