The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0557-2019·Announced 2019-03-20

King Bio Recalls Homeopathic Arnica Due to Microbial Contamination

King Bio Inc. is recalling Dr. King's Natural Medicine Homeopathic Advanced Arnica 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 recall is classified as FDA Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. Per the rubric, FDA Class I recalls are assigned a severity score of 4 or higher.

Plain-English summary

King Bio Inc. is recalling Dr. King's Natural Medicine Homeopathic Advanced Arnica, 2 fl. oz. (59 mL), due to microbial contamination. The recall involves 11,055 bottles of the product, which is identified by NDC 57955-5984-2 and UPC 357955598428.

The affected lots include 010518D (Exp. 01/20), 033116E (Exp. 03/19), 080916H (Exp. 08/19), 080917C (Exp. 08/2019), and 081015C (Exp. 08/18). The product was distributed nationwide in the United States, as well as in Canada and Australia.

Consumers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the place of purchase or disposed of according to local regulations.

The recalled product

Product
Dr. King's Natural Medicine Homeopathic Advanced Arnica, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955598428, NDC 57955-5984-2
Manufacturer
King Bio Inc.
Category
Drug — Homeopathic Medicine
Hazard
Affected units
11,055

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)

  • Lot Numbers: 010518D Exp. 01/20
  • 033116E Exp. 03/19
  • 080916H Exp. 08/19
  • 080917C Exp. 08/2019
  • 081015C Exp. 08/18

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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