The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0619-2022·Announced 2022-03-02

Perrigo Nasal Oxymetazoline Spray Recalled for Contaminated Excipient

Perrigo Company PLC is recalling approximately 10,800 bottles of NASAL Maximum Strength No Drip Nasal Spray (Oxymetazoline HCl 0.05%) nationwide due to manufacturing with a contaminated excipient supplied by their ingredient vendor.

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 recall by the FDA. The source text does not report any illnesses, injuries, or adverse events—only a manufacturing deviation involving a contaminated excipient. Per the rubric, FDA Class II recalls without reported hospitalization or significant injury reports typically score as 2 (Moderate), and the absence of reported harm indicates a precautionary action.

Plain-English summary

Perrigo Company PLC is recalling NASAL Maximum Strength No Drip Nasal Spray (Oxymetazoline HCl 0.05%, 1 FL Oz / 30 mL bottles, NDC 41250-388-10) distributed nationwide. The recall affects approximately 10,800 bottles from Batch 1FK1164 with expiration date 01/31/2023.

The products were manufactured using a contaminated excipient (inactive ingredient) that was recalled by the supplier. This deviation from good manufacturing practices poses a potential quality and safety concern.

Consumers who have purchased this product should stop using it. Those with questions about the recall should contact their healthcare provider or pharmacist. The product was distributed nationwide by Meijer Distribution, Inc., Grand Rapids, MI.

The recalled product

Product
NASAL (OXYMETAZOLINE HCL)
Brand
NASAL
Manufacturer
Perrigo Company PLC
Category
Drug — Over-the-Counter Nasal Decongestant
Hazard
Affected units
10,800

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: 1FK1164
  • Exp 01/31/2023

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 51 recalled by Perrigo Company PLC 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 51 products in this recall →

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