The Recall Desk
Agency classClass IIOur severity:HighFDA (Food)·F-1481-2019·Announced 2019-06-26

APS BioGroup Recalls Immulox Supplement Due to Stenotrophomonas Contamination

APS BioGroup is recalling Immulox polypeptide supplements due to elevated levels of Stenotrophomonas maltophilia. The recall covers 7,132 units distributed nationwide and in Switzerland.

The agency’s classification

FDA (Food): 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 3/5 (High).

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 illnesses, which aligns with the rubric criteria for a High severity score.

Plain-English summary

APS BioGroup, Inc. is recalling Immulox, an Immune Balance Polypeptide Supplement with Naturally Occurring Bioactive Peptides. The recall is being conducted because additional testing determined that the product contains elevated levels of the organism Stenotrophomonas maltophilia.

The affected product is identified by UPC 1 82863 000064 6 and has a size of 5.07 oz (150 ml). A total of 7,132 units were distributed nationwide and in Switzerland. The recall includes specific lots manufactured on April 21, 2019, with expiration dates of 04/2021. The source text does not specify any military, government, or VA consignees.

Consumers should check their inventory for the specific lot numbers and UPC listed in the recall notice. If they possess the affected product, they should stop using it and follow the instructions provided by the recalling firm for disposal or return.

The recalled product

Product
Immulox, UPC 1 82863 000064 6. Immune Balance Polypeptide Supplement with Naturally Occuring Bioactive Peptides. 5.07 oz (150 ml)
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 →

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