Signature Care Nasal Decongestant Recalled for Contaminated Excipient
Perrigo Company PLC is recalling Signature Care Nasal Decongestant because the product was manufactured with a contaminated excipient that was itself recalled by its supplier. The recall affects approximately 14,784 bottles distributed nationwide.
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 CGMP deviation related to a contaminated excipient. The source text does not report any illnesses, injuries, or adverse events associated with the product. In the absence of reported harm and without evidence of high-risk pathogens or direct safety hazard, this qualifies as a moderate-severity precautionary recall.
Plain-English summary
Perrigo Company PLC is recalling Signature Care Nasal Decongestant (Oxymetazoline Hydrochloride 0.05%), 1 FL Oz (30 mL) bottles, due to Current Good Manufacturing Practice (CGMP) deviations. The products were manufactured using a contaminated excipient that had been recalled by the excipient supplier.
The affected product includes NDC 21130-813-10 with the following batch codes and expiration dates: Batch 1BK0716 (Exp 12/31/2022); Batch 1FK1251 (Exp 02/28/2023); and Batch 1HK1196 (Exp 02/28/2023). Approximately 14,784 bottles were distributed nationwide in the USA through Better Living Brands LLC.
Consumers who have purchased this product should stop using it and contact their pharmacist or healthcare provider if they have questions or concerns. The product should be returned to the place of purchase.
The recalled product
- Product
- SIGNATURE CARE NASAL DECONGESTANT (OXYMETAZOLINE HYDROCHLORIDE)
- Brand
- SIGNATURE CARE NASAL DECONGESTANT
- Manufacturer
- Perrigo Company PLC
- Category
- Drug — Nasal Decongestant / OTC
- Affected units
- 14,784
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: 1BK0716
- Exp 12/31/2022
- 1FK1251
- 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.
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