Perrigo Nasal Spray Recalled for Contaminated Excipient
Perrigo Company PLC is recalling approximately 15,264 bottles of NASAL Maximum Strength No Drip Nasal Spray (Oxymetazoline HCl 0.05%) distributed nationwide because the product was manufactured with a contaminated excipient that was itself recalled from the 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 a Class II recall involving a manufacturing deviation (use of a contaminated excipient). The source text contains no reports of illness, injury, or confirmed harm. The hazard is the result of a process failure rather than a confirmed dangerous substance in the final product. Under the rubric, Class II recalls with no reported hospitalization or illness are typically Moderate (2).
Plain-English summary
Perrigo Company PLC is recalling NASAL Maximum Strength No Drip Nasal Spray containing Oxymetazoline HCl 0.05% (1 FL Oz per bottle). The recall affects approximately 15,264 bottles distributed nationwide in the USA. The product was manufactured using a contaminated excipient (an inactive ingredient) that was previously recalled by the excipient supplier. This represents a deviation from Good Manufacturing Practice (CGMP) requirements.
The affected batches are 1BK0964 (expiration 01/31/2023) and 1FK1164 (expiration 01/31/2023), with NDC 11822-6319-1. The product was distributed by Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011.
Consumers who have purchased this product should stop using it. Those with questions or concerns should contact Perrigo Company or Rite Aid. Healthcare providers and consumers are encouraged to report adverse events to the FDA.
The recalled product
- Product
- NASAL (OXYMETAZOLINE HYDROCHLORIDE)
- Brand
- NASAL
- Manufacturer
- Perrigo Company PLC
- Category
- Drug — Nasal Decongestant / OTC
- Affected units
- 15,264
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 (3)
- Batch: 1BK0964
- Exp 01/31/2023
- 1FK1164
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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