The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0605-2022·Announced 2022-03-02

CareOne Severe Congestion Nasal Spray Recalled for Contaminated Excipient

Perrigo Company is recalling CareOne Severe Congestion Nasal Spray due to contaminated excipient used during manufacturing. The nasal spray was made with an excipient that had been recalled from the supplier.

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 an FDA Class II recall involving a manufacturing deviation with a contaminated excipient. The source does not report any illnesses, injuries, or hospitalizations. No specific hazard beyond the general manufacturing deviation is detailed in the source text.

Plain-English summary

Perrigo Company PLC is recalling CareOne Severe Congestion Nasal Spray (Oxymetazoline HCl 0.05%, 1 FL Oz per bottle) distributed nationwide in the USA. The recall affects approximately 7,200 bottles.

The products were manufactured using a contaminated excipient that had been recalled by the excipient supplier. This represents a deviation from good manufacturing practices (CGMP).

Affected lots are Batch 1BK0716 (expiration 12/31/2022) and Batch 1FK1251 (expiration 02/28/2023), with NDC 41520-108-10. Consumers who have purchased this product should stop using it and consult with their healthcare provider if they have concerns.

The recalled product

Product
CAREONE SEVERE CONGESTION NASAL (OXYMETAZOLINE HYDROCHLORIDE)
Brand
CAREONE SEVERE CONGESTION NASAL
Manufacturer
Perrigo Company PLC
Category
Drug — Over-the-Counter Nasal Decongestant
Hazard
Affected units
7,200

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 (4)

  • Batch: 1BK0716
  • Exp 12/31/2022
  • 1FK1251
  • Exp 02/28/2023

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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