The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0621-2022·Announced 2022-03-02

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.

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 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
Hazard
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.

See all 51 products in this recall →

Related recalls

Same brand · NASAL

Same manufacturer · Perrigo Company PLC

See all →

Same hazard · contaminated excipient

See all →

Similar recalls