The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0668-2019·Announced 2019-03-20

King Bio Children's Ear Relief Formula Recalled for Microbial Contamination

King Bio Inc. is recalling 205 bottles of Dr. King's Natural Medicine Children's Ear Relief Formula 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of at least 4 per the rubric. The hazard involves microbial contamination, a significant health risk.

Plain-English summary

King Bio Inc. is recalling 205 bottles of Dr. King's Natural Medicine for kids! Children's Ear Relief Formula Homeopathic, 2 fl. oz. (59 mL). The recall is due to microbial contamination. The affected product has the UPC 357955531524 and NDC 57955-0416-2.

The recalled lots include 050216P (Exp. 05/2019), 072516G (Exp. 07/2019), and 112315B (Exp. 11/2018). The product was distributed nationwide in the U.S.A., as well as in Canada and Australia.

Consumers should check their inventory for the specific lot numbers and expiration dates listed above. If they possess the affected product, they should stop using it and contact the recalling firm for further instructions.

The recalled product

Product
Dr. King's Natural Medicine for kids! Children's Ear Relief Formula Homeopathic, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside dr. Asheville, NC 28806 USA, UPC 357955531524, NDC 57955-0416-2
Manufacturer
King Bio Inc.
Category
Drug — Homeopathic
Hazard
Affected units
205

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 (3)

  • Lots: 050216P Exp. 05/2019
  • 072516G Exp. 07/2019
  • 112315B Exp. 11/2018

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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