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.
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: 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
- Hazard
- contaminated-excipient
- cgmp-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 (4)
- Batch: 1BK0716
- Exp 12/31/2022)
- 1FK1251
- Exp 02/28/2023
Distribution
Distributed nationwide across the United States.
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Same brand · CAREONE SEVERE CONGESTION NASAL
- ModerateCareOne Severe Congestion Nasal Spray Recalled for Contaminated Excipient
FDA (Drugs) · 2022-03-02
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