The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0608-2022·Announced 2022-03-02

Nasal Oxymetazoline Spray Recalled for Contaminated Excipient

Perrigo Company is recalling approximately 9,888 bottles of NASAL Severe Congestion Nasal Spray due to contamination from a recalled excipient used during manufacturing. The product was distributed nationwide.

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 identifies a CGMP deviation involving a contaminated excipient but does not report any illnesses, injuries, or deaths. The recall is precautionary in nature.

Plain-English summary

Perrigo Company PLC is recalling approximately 9,888 bottles of NASAL Severe Congestion Nasal Spray (Oxymetazoline HCl 0.05%, No Drip Plus Menthol, 1 FL Oz / 30 mL, NDC 11822-6378-1). The recall affects product with Batch 11BK0827 and expiration date 12/31/2022.

The recall was initiated due to current good manufacturing practices (CGMP) deviations. The product was manufactured using a contaminated excipient—an inactive ingredient—that had been recalled by the excipient supplier.

The affected product was distributed nationwide in the USA and was distributed by Rite Aid. Consumers who have purchased this product should stop using it and consult a healthcare provider with any questions or concerns about prior use.

The recalled product

Product
NASAL (OXYMETAZOLINE HYDROCHLORIDE)
Brand
NASAL
Manufacturer
Perrigo Company PLC
Category
Drug — Over-the-Counter Nasal Decongestant
Hazard
Affected units
9,888

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: 11BK0827
  • 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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