The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0625-2022·Announced 2022-03-02

TOPCARE NASAL Oxymetazoline HCl Recalled Due to Contaminated Excipient

Perrigo Company PLC is recalling TOPCARE NASAL (Oxymetazoline HCl 0.05%) nasal spray nationwide because products were manufactured with a contaminated excipient obtained from a supplier whose material was recalled.

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: The FDA classified this as a Class II recall. The source text identifies a CGMP deviation involving a contaminated excipient but does not report any illnesses, injuries, or hospitalizations. This is a precautionary manufacturing defect recall.

Plain-English summary

Perrigo Company PLC is recalling TOPCARE NASAL No Drip Nasal Spray (Oxymetazoline HCl 0.05%, 1 FL Oz bottles) distributed by TOPCO ASSOCIATES LLC nationwide. The recall affects 13,824 bottles with Batch 1FK1233 and expiration date 01/31/2023 (NDC 36800-388-10).

The products were manufactured with a contaminated excipient—an inactive ingredient—that was obtained from a supplier whose material had been recalled. This is a Current Good Manufacturing Practice (CGMP) deviation.

Consumers who have purchased this product should stop using it. Anyone with questions or concerns should contact their healthcare provider or pharmacist.

The recalled product

Product
TOPCARE NASAL (OXYMETAZOLINE HCL)
Brand
TOPCARE NASAL
Manufacturer
Perrigo Company PLC
Category
Drug — Nasal Decongestant / OTC
Hazard
Affected units
13,824

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 (2)

  • Batch: 1FK1233
  • 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 →

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