The Recall Desk
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.

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, 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
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: 1BK0827
  • Exp 12/31/2022

Distribution

Distributed nationwide across the United States.