The Recall Desk
SevereFDA (Drugs)·D-155-2013·Announced 2013-02-13

Zicam Nasal Spray Recalled for Burkholderia cepacia Contamination

Matrixx Initiatives Inc is recalling Zicam Extreme Congestion Relief nasal spray due to potential contamination with Burkholderia cepacia. The recall covers 46,752 bottles distributed nationwide.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.

Plain-English summary

Matrixx Initiatives Inc is recalling Zicam Extreme Congestion Relief (oxymetazoline HCl) nasal gel, 0.05%, 0.50 fl. oz. (15 mL) spray bottles. The recall is due to the potential for microbial contamination with Burkholderia cepacia. The affected product is identified by Lot # 2J23 and an expiration date of 09/15.

The recall involves 46,752 bottles of the product, which were distributed nationwide. The product is developed and distributed by Zicam LLC, a wholly owned subsidiary of Matrixx Initiatives Inc.

Consumers with the affected product should stop using it and contact the manufacturer for instructions on how to return the product or obtain a refund.

The recalled product

Product
Zicam Extreme Congestion Relief (oxymetazoline HCl) nasal gel, 0.05%, 0.50 fl. oz. (15 mL) spray bottle, Developed and distributed by Zicam LLC, Scottsdale, Arizona 85255, a wholly owned subsidiary of Matrixx Initiatives Inc, NDC 62750-005-10, UPC 7 32216 20410 0.
Manufacturer
Matrixx Initiatives Inc
Category
Drug — Nasal Spray
Hazard
Affected units
46,752

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)

  • Lot # 2J23
  • Exp 09/15

Distribution

Distributed nationwide across the United States.

Related recalls

Same hazard · microbial contamination

See all →