The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0617-2022·Announced 2022-03-02

Nasal Decongestant Spray Recalled for Contaminated Excipient

Perrigo Company is recalling NASAL oxymetazoline HCl nasal spray nationwide due to contaminated excipient used in manufacturing. The affected product was distributed to retailers including Kroger.

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: This is an FDA Class II recall involving a manufacturing contamination issue. The source text does not report any illnesses, injuries, or adverse events; the recall is based on a CGMP deviation (use of a recalled excipient). Under the rubric, contamination without reported harm and no Class I designation typically scores 2 (Moderate).

Plain-English summary

Perrigo Company PLC is recalling NASAL brand nasal spray decongestant (oxymetazoline HCl 0.05%, 1 FL Oz bottles) due to current good manufacturing practice (CGMP) deviations. The product was manufactured with a contaminated excipient that had itself been recalled by the excipient supplier.

Approximately 7,632 bottles were affected, batch 1BK0826 with expiration date 12/31/2022. The product was distributed nationwide in the USA and distributed through The Kroger Co.

Consumers who have purchased this product should stop using it. Individuals with questions or concerns should consult their healthcare provider or pharmacist.

The recalled product

Product
NASAL (OXYMETAZOLINE HCL)
Brand
NASAL
Manufacturer
Perrigo Company PLC
Category
Drug — OTC Nasal Decongestant
Hazard
Affected units
7,632

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.

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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