The Recall Desk
CriticalFDA (Drugs)·D-0549-2019·Announced 2019-03-20

King Bio Recalls Homeopathic Ear Relief Formula Due to Microbial Contamination

King Bio Inc. is recalling Dr. King's Natural Medicine Homeopathic Ear Relief 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 agency classification is FDA 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 425 bottles of Dr. King's Natural Medicine Homeopathic Ear Relief Formula, 2 fl. oz. (59 mL), due to microbial contamination. The product is identified by NDC 57955-0918-2 and UPC 357955515722.

The recall covers two specific lot numbers: 032816B with an expiration date of 03/19, and 101917B with an expiration date of 10/19. The affected 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
Dr. King's Natural Medicine Homeopathic Ear Relief Formula, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955515722, NDC 57955-0918-2
Manufacturer
King Bio Inc.
Affected units
425

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)

  • Lot Numbers: 032816B Exp. 03/19
  • 101917B Exp. 10/19

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 →