Equaline Nasal Spray Recalled for Contaminated Excipient
Perrigo Company is recalling Equaline Nasal Spray (oxymetazoline HCl 0.05%) due to manufacturing with a contaminated excipient obtained from a recalled supplier. The recall affects approximately 2,664 bottles distributed nationwide.
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 involving a manufacturing deviation (use of a recalled excipient). The source text contains no reports of illness, injury, or adverse events. Under the rubric, Class II recalls without reported hospitalization are typically Moderate (2) unless they involve high-risk pathogens or serious injury—neither of which apply here.
Plain-English summary
Perrigo Company PLC is recalling Equaline Nasal (Severe Congestion Nasal Spray, No Drip Plus Menthol), a nasal decongestant spray containing oxymetazoline hydrochloride 0.05%, distributed by SUPERVALU INC. in Eden Prairie, Minnesota. The product is available in 1 FL Oz (30 mL) bottles with NDC 41163-343-10.
The recall was initiated because the product was manufactured using a contaminated excipient (an inactive ingredient) that had itself been recalled by the excipient supplier. This represents a deviation from current Good Manufacturing Practice (CGMP) standards.
The affected batch is 1FK1251 with expiration date 02/28/2023. Approximately 2,664 bottles were distributed nationwide in the USA.
Consumers should stop use of the recalled product and dispose of it safely. Consult a healthcare provider or pharmacist if you have questions or concerns about this recall.
The recalled product
- Product
- EQUALINE NASAL (OXYMETAZOLINE HYDROCHLORIDE)
- Brand
- EQUALINE NASAL
- Manufacturer
- Perrigo Company PLC
- Affected units
- 2,664
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: 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.
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