The Recall Desk
HighFDA (Food)·F-1479-2019·Announced 2019-06-26

APS BioGroup Recalls Viralox Oral Spray Due to Bacterial Contamination

APS BioGroup is recalling Viralox Immune Balancing Polypeptide Oral Spray because testing found elevated levels of Stenotrophomonas maltophilia bacteria.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk pathogen (Stenotrophomonas maltophilia) without reported illness, which aligns with the rubric criteria for a High severity score.

Plain-English summary

APS BioGroup, Inc. is recalling Viralox Immune Balancing Polypeptide Oral Spray, 5.0 fl. oz. (150 ml), due to elevated levels of a specific bacteria. The recall affects 7,132 total units manufactured on April 21, 2019, with expiration dates of 04/2021. The product was distributed nationwide and in Switzerland.

The recall was initiated after additional testing determined that the organism causing the elevated APC levels is Stenotrophomonas maltophilia. The affected lots include 9068-2, 9068-3, 9068-4, 9068-5, and 9068-6, all associated with Bulk # UL-7.

Consumers who have purchased this product should stop using it and contact the recalling firm for instructions on how to return or dispose of the product. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
Viralox, UPC 8 63784 00015 0. Immune Balancing Ploypeptide Oral Spray. 5.0 fl. oz. (150 ml) Oral Spray.
Manufacturer
APS BioGroup, Inc
Category
Food — Dietary Supplement
Hazard
Affected units
7,132

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 (12)

  • Manufactured April 21
  • 2019. Lot 9068-2
  • Item # 4044
  • Bulk # UL-7
  • Exp. Date 04/2021
  • Lot 9068-3
  • Item # 4691
  • Lot 9068-4
  • Item # 4181
  • Lot 9068-5
  • Item # 00064
  • Lot 9068-6

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by APS BioGroup, Inc under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · APS BioGroup, Inc

See all →

Same hazard · bacterial contamination

See all →