The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0530-2019·Announced 2019-03-20

King Bio Homeopathic Allergy Product Recalled for Microbial Contamination

King Bio Inc. is recalling Dr. King's Natural Medicine Homeopathic Regional Allergies Southern U.S. 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 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, meeting the criteria for a Severe rating.

Plain-English summary

King Bio Inc. is recalling 11,798 bottles of Dr. King's Natural Medicine Homeopathic Regional Allergies Southern U.S. (2 fl. oz.) because of microbial contamination. The product is identified by NDC 57955-0760-2 and UPC 357955518426.

The affected lots include 022717K (Exp. 02/20), 030816D (Exp. 03/19), 030817R (Exp. 03/19), 061815H (Exp. 06/18), and 030418A (Exp. 03/20). These products were distributed nationwide in the U.S., as well as in Canada and Australia.

Consumers should check their inventory for these specific lot numbers and expiration dates. If the product matches the recalled items, consumers should stop using it and contact King Bio Inc. for instructions on disposal or return.

The recalled product

Product
Dr. King's Natural Medicine Homeopathic Regional Allergies Southern U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955518426, NDC 57955-0760-2
Manufacturer
King Bio Inc.
Category
Drug — Homeopathic
Hazard
Affected units
11,798

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: 022717K Exp. 02/20
  • 030816D Exp. 03/19
  • 030817R Exp. 03/19
  • 061815H Exp. 06/18
  • 030418A Exp. 03/20

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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