The Recall Desk
Agency classClass IIOur severity: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.

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: 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
Category
Drug — Nasal Decongestant / OTC
Hazard
Affected units
2,302

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.

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 →

Related recalls

Same brand · NASAL

Same manufacturer · Perrigo Company PLC

See all →

Same hazard · contamination

See all →

Similar recalls