The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0627-2022·Announced 2022-03-02

DG Health Sinus Severe nasal decongestant recalled for contaminated excipient

Perrigo Company is recalling DG Health Sinus Severe nasal decongestant because the product was manufactured with a contaminated excipient that was recalled from the supplier. Three batches are affected.

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. No illnesses, injuries, or hospitalizations are reported in the source text. The hazard is a manufacturing process deviation (contaminated excipient) rather than a confirmed harmful substance, making this a precautionary recall.

Plain-English summary

Perrigo Company PLC is recalling DG Health Sinus Severe (Oxymetazoline Hydrochloride 0.05% Nasal Decongestant with Menthol), a non-prescription nasal decongestant sold in 1 FL Oz bottles. The recall affects three batches: 1BK0931 (expiration 12/31/2022), 1CK0900 (expiration 01/31/2023), and 1HK1196 (expiration 02/28/2023).

The product is being recalled because it was manufactured using a contaminated excipient that was itself recalled by the supplier.

The product was distributed nationwide in the USA. Consumers who have purchased affected batches should stop using the product and consult their healthcare provider or poison control if they have questions or concerns about their use.

The recalled product

Product
DG HEALTH SINUS SEVERE (OXYMETAZOLINE HYDROCHLORIDE)
Brand
DG HEALTH SINUS SEVERE
Manufacturer
Perrigo Company PLC
Category
Drug — OTC Nasal Decongestant
Hazard
Affected units
79,776

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 (6)

  • Batch: 1BK0931
  • Exp 12/31/2022
  • 1CK0900
  • Exp 01/31/2023
  • 1HK1196
  • Exp 02/28/2023

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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