Oxymetazoline HCl Nasal Spray Recalled for Contaminated Excipient
Perrigo Company PLC is recalling NASAL Maximum Strength No Drip Nasal Spray (oxymetazoline HCl 0.05%) because the product was manufactured with a contaminated excipient from a recalled 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: The FDA classified this as a Class II recall. The source text does not report any illnesses or injuries from the contaminated excipient, and the hazard is identified as a manufacturing deviation rather than a specific identified pathogen or injury risk. This fits the rubric criterion for moderate severity: a voluntary precautionary recall with no reported adverse health outcomes.
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) distributed nationwide in the USA. The product was manufactured with a contaminated excipient that had been recalled by the excipient supplier, representing a deviation from good manufacturing practices (CGMP).
The recall affects approximately 3,744 bottles with batch 1BK0826 and expiration date of 12/31/2022. The product was distributed by The Kroger Co., Cincinnati, Ohio and carries NDC 30142-388-10.
Consumers who have purchased this product should stop using it. The FDA classifies this as a Class II recall. Those with questions should contact Perrigo Company PLC or consult their healthcare provider.
The recalled product
- Product
- NASAL (OXYMETAZOLINE HCL)
- Brand
- NASAL
- Manufacturer
- Perrigo Company PLC
- Category
- Drug — OTC Nasal Decongestant
- 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 (2)
- Batch: 1BK0826
- Exp 12/31/2022
Distribution
Distributed nationwide across the United States.
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