The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0623-2022·Announced 2022-03-02

Equaline Nasal Oxymetazoline HCl Nasal Spray Recalled for Contaminated Excipient

Perrigo Company PLC is recalling 1,560 bottles of Equaline Nasal No Drip Nasal Spray nationwide due to contaminated excipient used during manufacturing. The contaminated ingredient was sourced from a recalled excipient supplier.

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 for a drug manufactured with a CGMP deviation involving a contaminated excipient from a recalled supplier. The source text does not report any illness, injury, or hospitalization, and the specific nature and risk posed by the contaminated excipient are not disclosed. This aligns with a Moderate severity classification for a precautionary CGMP-based recall without reported adverse events.

Plain-English summary

Perrigo Company PLC is recalling Equaline Nasal No Drip Nasal Spray (Oxymetazoline HCl 0.05%, 1 FL Oz / 30 mL bottles) distributed nationwide in the USA. The recall affects 1,560 bottles with batch number 1BK0964 and expiration date 01/31/2023. NDC: 41163-703-10.

The product was manufactured with a contaminated excipient that was itself recalled by the excipient supplier. This represents a deviation from Current Good Manufacturing Practices (CGMP).

Consumers who have purchased this product should stop using it. Consult a healthcare provider if you have questions about your health or exposure to the recalled product.

The recalled product

Product
EQUALINE NASAL (OXYMETAZOLINE HCL)
Brand
EQUALINE NASAL
Manufacturer
Perrigo Company PLC
Category
Drug — Nasal Decongestant / OTC
Hazard
Affected units
1,560

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: 1BK0964
  • Exp 01/31/2023

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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