The Recall Desk
CriticalFDA (Drugs)·D-0901-2019·Announced 2019-03-20

King Bio Aquaflora Candida Control Program Recalled for Microbial Contamination

King Bio Inc. is recalling Aquaflora Phase II Candida Control Program bottles 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 classified this recall as Class I, which meets the rubric criteria for a Critical severity score (5).

Plain-English summary

King Bio Inc. is recalling 2,248 bottles of Aquaflora Phase II Candida Control Program, a homeopathic formula. The recall was initiated because the product is subject to microbial contamination.

The affected product is a 16 fl. oz. (473 mL) bottle with UPC 357955160267 and NDC 57955-1602-6. The recall covers specific lots with expiration dates ranging from July 2018 to January 2020. The product was distributed nationwide in the United States, 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 FDA 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 Phase II Candida Control Program, Net 16 fl. oz. (1 PT) 473 mL, Homeopathic Formula, Manufactured by: King Bio, Inc. 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955160267, NDC 57955-1602-6
Manufacturer
King Bio Inc.
Category
Drug — Homeopathic Formula
Hazard
Affected units
2,248

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 (5)

  • Lots: 010518G Exp. 07/18
  • 011617F Exp. 01/20
  • 021016G Exp. 02/19
  • 051716P Exp. 02/19
  • 072315A Exp. 07/18

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 →

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Same hazard · microbial contamination

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