The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0607-2022·Announced 2022-03-02

CareOne Severe Congestion Nasal Spray Recalled Due to Contaminated Excipient

Perrigo Company PLC is recalling 3,192 bottles of CareOne Severe Congestion Nasal Spray (oxymetazoline HCl 0.05%, 1 FL Oz) distributed nationwide because the products were manufactured with a contaminated excipient that was itself 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, and the source text does not report any illnesses, injuries, or deaths. The hazard is related to manufacturing deviations involving a contaminated excipient, which constitutes a process/quality issue rather than a confirmed safety event. Class II recalls with no reported adverse events typically score at the Moderate level.

Plain-English summary

Perrigo Company PLC is recalling CareOne Severe Congestion Nasal Spray, No Drip Plus Menthol (oxymetazoline hydrochloride 0.05%, 1 FL Oz / 30 mL per bottle) distributed nationwide in the USA. The affected product is identified by NDC 41520-108-10 with batch numbers 1BK0716 (expiration 12/31/2022) and 1FK1251 (expiration 02/28/2023). A total of 3,192 bottles are included in this recall.

The recall was issued because the products were manufactured using a contaminated excipient that had itself been recalled from the supplier. This represents a manufacturing deviation from good manufacturing practice (CGMP) standards.

The FDA has classified this as a Class II recall. Consumers who have purchased this product should stop using it. Those with questions or concerns should consult their healthcare provider or pharmacist.

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
3,192

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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