The Recall Desk
ModerateFDA (Drugs)·D-0629-2022·Announced 2022-03-02

Perrigo Nasal Spray Recalled for Contaminated Excipient

Perrigo Company PLC is recalling NASAL Maximum Strength Nasal Spray (oxymetazoline HCl 0.05%) due to manufacturing with a contaminated excipient that was itself recalled from the supplier. The recall affects one batch 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: The recall is classified as FDA Class II and involves a contamination issue with an excipient from a supplier. However, the source text does not report any illnesses, injuries, or hospitalizations related to the contaminated product, and no specific hazard from the excipient is identified, making this a precautionary recall with moderate concern.

Plain-English summary

Perrigo Company PLC is recalling NASAL Maximum Strength Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant with Menthol (1 FL Oz / 30 mL bottles, NDC 41250-989-10), distributed nationwide in the USA.

The recall was initiated because the product was manufactured using a contaminated excipient (inactive ingredient) that had been recalled by the excipient supplier. The recalled batch is 1BK0716 with expiration date 12/31/2022. A total of 144 bottles were affected.

This recall resulted from manufacturing deviations related to current Good Manufacturing Practice (CGMP) requirements. Consumers should stop using the recalled batch and consult their pharmacist or physician with questions.

The recalled product

Product
NASAL (OXYMETAZOLINE HYDROCHLORIDE)
Brand
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 (2)

  • Batch: 1BK0716
  • Exp 12/31/2022

Distribution

Distributed nationwide across the United States.