The Recall Desk
CriticalFDA (Drugs)·D-0900-2019·Announced 2019-03-20

King Bio Recalls Aquaflora Candida Control Formula Due to Microbial Contamination

King Bio Inc. is recalling Aquaflora High Potency Candida Control Program Homeopathic Formula due to microbial contamination. The product was distributed in the U.S., Canada, and Australia.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The FDA has classified this recall as Class I, which corresponds to a reasonable probability that use of the product may cause serious adverse health consequences or death, meeting the criteria for a Critical severity score.

Plain-English summary

King Bio Inc. is recalling Aquaflora High Potency Candida Control Program Homeopathic Formula, Net 16 fl. oz. (1 pt) 473 mL, due to microbial contamination. The recall involves 5,000 bottles of the product, which is manufactured by King Bio, Inc. in Asheville, NC.

The affected product is identified by UPC 357955160366 and NDC 57955-1603-6. Specific lots subject to the recall include 011017A (Exp. 01/20), 033116T (Exp. 03/19), 052516R (Exp. 05/19), and 122815A (Exp. 12/18). The product was distributed nationwide in the U.S.A., as well as in Canada and Australia.

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

The recalled product

Product
Aquaflora High Potency Candida Control Program Homeopathic Formula, Net 16 fl. oz. (1 pt) 473 mL, Manufactured by: King Bio, Inc. 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955160366, NDC 57955-1603-6
Manufacturer
King Bio Inc.
Affected units
5,000

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)

  • Lots: 011017A Exp. 01/20
  • 033116T Exp. 03/19
  • 052516R Exp. 05/19
  • 122815A Exp. 12/18

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 →