The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0673-2019·Announced 2019-03-20

King Bio Recalls Kids Sleep Aid Due to Microbial Contamination

King Bio Inc. is recalling Dr. King's Natural Medicine Kids Sleep Aid Homeopathic 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 meets the rubric criteria for a Critical severity score.

Plain-English summary

King Bio Inc. is recalling Dr. King's Natural Medicine Kids Sleep Aid Homeopathic, 2 fl. oz. (59 mL), due to microbial contamination. The recall involves 2,404 bottles with lot numbers 063016D (Exp. 06/2019) and 081016F (Exp. 08/2019).

The affected product was distributed nationwide in the United States, as well as in Canada and Australia. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.

Consumers should stop using the product and return it to the place of purchase or contact King Bio Inc. for further instructions.

The recalled product

Product
Dr. King's Natural Medicine Kids Sleep Aid Homeopathic, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside dr. Asheville, NC 28806 USA, UPC 357955042426, NDC 57955-0424-2
Manufacturer
King Bio Inc.
Category
Drug — Homeopathic
Hazard
Affected units
2,404

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 (2)

  • Lots: 063016D Exp. 06/2019
  • 081016F Exp. 08/2019

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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