The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0604-2022·Announced 2022-03-02

Perrigo Severe Congestion Nasal Spray recalled for contaminated excipient

Perrigo Company is recalling Severe Congestion Nasal Spray, No Drip Plus Menthol because the product was manufactured with a contaminated excipient that was 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: The FDA classified this as a Class II recall. The source text does not report any illnesses or injuries, and the hazard stems from a manufacturing deviation involving a recalled excipient. This is consistent with a precautionary or low-risk contamination recall.

Plain-English summary

Perrigo Company PLC is recalling Severe Congestion Nasal Spray, No Drip Plus Menthol (Oxymetazoline HCl 0.05% Nasal Decongestant), 1 FL Oz (30 mL) bottles, packaged for Big Lots Stores, Inc. The recall affects approximately 3,168 bottles distributed nationwide in the USA. Batch 1BK0827 with expiration date 12/31/2022 is being recalled (NDC: 50594-719-10).

The product was manufactured with a contaminated excipient that was recalled from the excipient supplier. This represents a deviation from current Good Manufacturing Practice (CGMP) standards.

Consumers who have purchased this product should stop using it and contact Big Lots or a healthcare provider with questions about their health or the recall.

The recalled product

Product
Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, Packaged by Perrigo Company for: Big Lots Stores, Inc., P.O. Box 28523, Columbus, OH 43228-0523. NDC: 50594-719-10
Manufacturer
Perrigo Company PLC
Category
Drug — Nasal Decongestant
Hazard
Affected units
3,168

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: 1BK0827
  • Exp 12/31/2022

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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