The Recall Desk
ModerateFDA (Drugs)·D-0624-2022·Announced 2022-03-02

Oxymetazoline Nasal Spray Recalled for Contaminated Excipient

Perrigo Company is recalling Maximum Strength No Drip Nasal Spray containing oxymetazoline HCl because it was manufactured with a contaminated excipient obtained 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 does not report any illnesses, injuries, or confirmed harm from the contaminated excipient, only a CGMP deviation involving use of a recalled excipient. This is a precautionary manufacturing-practice violation rather than a confirmed hazardous condition with reported adverse effects.

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, NDC 30142-388-10) distributed by The Kroger Co. The recall affects 36,864 bottles with batch number 1BK0826 and expiration date 12/31/2022, distributed nationwide in the USA.

The product was manufactured using a contaminated excipient that was itself recalled from the excipient supplier. This constitutes a deviation from current good manufacturing practice (CGMP) standards. The affected lot was produced and distributed before the excipient recall was identified.

Consumers in possession of affected bottles should stop using the product and contact Perrigo Company or consult with a healthcare provider. The product should not be used until the nature and extent of the contamination can be determined and confirmed to pose no health risk.

The recalled product

Product
NASAL (OXYMETAZOLINE HCL)
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: 1BK0826
  • Exp 12/31/2022

Distribution

Distributed nationwide across the United States.