The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0699-2019·Announced 2019-03-20

King Bio Arnica Cream Recalled for Microbial Contamination

King Bio Inc. is recalling Dr. King's Natural Medicine Soothing Advanced Arnica Pure Homeopathic Cream due to microbial contamination.

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 agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

King Bio Inc. is voluntarily recalling 17,527 tubes of Dr. King's Natural Medicine Soothing Advanced Arnica Pure Homeopathic Cream, 3 oz. (85 g). The recall is being conducted because the product is subject to microbial contamination.

The affected product is identified by NDC 57955-4000-3 and UPC 357955400035. Specific lots involved include 052616 (Exp. 05/19), 073118ZZ (Exp. 07/21), 040117ZZ (Exp. 06/19), 122717ZZ (Exp. 12/20), 040417ZZ (Exp. 04/20), and 091617ZZ (Exp. 09/20).

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 the product matches the recalled description, consumers should stop using it and contact the manufacturer for further instructions.

The recalled product

Product
Dr. King's Natural Medicine Soothing Advanced Arnica Pure Homeopathic Cream, 3 oz. (85 g), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955400035, NDC 57955-4000-3
Manufacturer
King Bio Inc.
Category
Drug — Topical Homeopathic
Hazard
Affected units
17,527

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 (6)

  • Lots: 052616 Exp. 05/19
  • 073118ZZ Exp. 07/21
  • 040117ZZ Exp. 06/19
  • 122717ZZ Exp. 12/20
  • 040417ZZ Exp. 04/20
  • 091617ZZ Exp. 09/20

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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