The Recall Desk
ModerateFDA (Drugs)·D-0626-2022·Announced 2022-03-02

Equate Nasal Spray Recalled for Contaminated Excipient Manufacturing Defect

Perrigo Company PLC is recalling Equate Nasal No Drip Nasal Spray because the product was manufactured with a contaminated excipient that was previously 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 an FDA Class II recall involving a manufacturing defect (contaminated excipient). The source text does not report any illnesses, injuries, or hospitalizations. The recall is precautionary based on a CGMP violation, which fits the "low-risk contamination" and "voluntary precautionary recalls" criteria for a Moderate (score 2) severity.

Plain-English summary

Perrigo Company PLC is recalling Equate Nasal No Drip Nasal Spray (Oxymetazoline HCl 0.05%, 1 FL Oz bottles) due to current good manufacturing practice (CGMP) deviations. The products were manufactured using a contaminated excipient—a material obtained from an excipient supplier—that was itself subject to recall.

The recalled product includes 178,128 bottles distributed nationwide in the USA. Affected batches are 1CK0897, 1FK1233, and 1FK1232, each with an expiration date of 01/31/2023. The product is identified by NDC 49035-388-10 and was distributed by Walmart Inc., Bentonville, AR 72716.

Consumers who have purchased this product should stop using it. Any customers with questions should contact Perrigo Company PLC or consult their healthcare provider.

The recalled product

Product
EQUATE NASAL (OXYMETAZOLINE HCL)
Brand
EQUATE NASAL
Manufacturer
Perrigo Company PLC
Hazard
  • contaminated-excipient
  • cgmp-violation

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 (4)

  • Batch: 1CK0897
  • 1FK1233
  • 1FK1232
  • Exp 01/31/2023

Distribution

Distributed nationwide across the United States.