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.
What this means for you
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
- contaminated-excipient
- cgmp-deviation
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.
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- ModerateDG Health Nasal Spray Recalled for Contaminated Excipient
FDA (Drugs) · 2022-03-02
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