The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0616-2022·Announced 2022-03-02

DG Health Nasal Spray Recalled for Contaminated Excipient

Perrigo Company is recalling DG Health Nasal (Oxymetazoline Hydrochloride) nasal spray because it was manufactured with a contaminated excipient obtained from a recalled 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 involving a manufacturing deviation (CGMP violation) with use of a contaminated excipient. No illnesses or injuries are reported in the source text, and the actual hazard from the contaminated excipient is not specified. The recall is precautionary in nature, warranting a Moderate severity classification.

Plain-English summary

Perrigo Company PLC is recalling DG HEALTH NASAL Maximum Strength No Drip Nasal Spray (Oxymetazoline HCl 0.05%, 1 FL Oz bottles) distributed nationwide in the United States. The affected product was distributed by Old East Main Co., Goodlettsville, Tennessee.

The recall was issued due to manufacturing deviations: the product was made using a contaminated excipient (an inactive ingredient) that had itself been recalled by the excipient supplier. A total of 123,408 bottles are affected across multiple batches (1BK0826 with expiration 12/31/2022; 1FK1232 and 1BK0964 with expiration 01/31/2023). The NDC is 55910-623-10.

Consumers who have purchased this product should stop using it and consult their healthcare provider or pharmacist if they have any questions or concerns about their use of this product.

The recalled product

Product
DG HEALTH NASAL (OXYMETAZOLINE HYDROCHLORIDE)
Brand
DG HEALTH NASAL
Manufacturer
Perrigo Company PLC
Category
Drug — OTC Nasal Decongestant
Hazard
Affected units
123,408

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 (5)

  • Batch: 1BK0826
  • Exp 12/31/2022)
  • 1FK1232
  • 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 →

Related recalls

Same brand · DG HEALTH NASAL

Same manufacturer · Perrigo Company PLC

See all →

Same hazard · contaminated excipient

See all →

Similar recalls