The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0521-2019·Announced 2019-03-20

King Bio Recalls Dr. King's aquaflora Candida Due to Microbial Contamination

King Bio Inc. is recalling Dr. King's aquaflora Candida High Potency due to microbial contamination. The product was distributed in the U.S., Canada, and Australia.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The FDA classified this recall as Class I, which per the rubric mandates a severity score of 5 (Critical) regardless of other factors.

Plain-English summary

King Bio Inc. is recalling Dr. King's aquaflora Candida High Potency, 8 fl. oz. (236 mL) bottles, due to microbial contamination. The recall involves 105,716 bottles of the product, which is identified by NDC 57955-8020-89 and UPC 35795580018.

The affected product was distributed nationwide in the United States, as well as in Canada and Australia. The recall covers multiple lot numbers with expiration dates ranging from November 2018 to June 2020.

Consumers who have purchased this product should stop using it and contact King Bio Inc. for further instructions or a refund. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product could cause serious adverse health consequences or death.

The recalled product

Product
Dr. King's aquaflora Candida High Potency, 8 fl. oz. (236 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 35795580018, NDC 57955-8020-89
Manufacturer
King Bio Inc.
Category
Drug — Dietary Supplement
Hazard
Affected units
105,716

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 (20)

  • Lot Numbers: 120217R Exp. 12/19
  • 102017C Exp. 10/19
  • 101017G Exp. 10/19
  • 111417C Exp. 11/19
  • 062818E Exp. 06/20
  • 122817B Exp. 12/19
  • 030818B Exp. 03/20
  • 010716A Exp. 01/19
  • 011617H Exp. 01/20
  • 012517M Exp. 01/20
  • 020717A Exp. 02/20
  • 021816A Exp. 02/19
  • 031016C Exp. 03/19
  • 031016D Exp. 03/19
  • 033016K Exp. 03/19
  • 052516J Exp. 05/19
  • 052918G Exp. 05/20
  • 062116A Exp. 06/19
  • 062818A Exp. 06/20
  • 062818F Exp. 06/20

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 465 recalled by King Bio Inc. 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 465 products in this recall →

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