The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0548-2019·Announced 2019-03-20

King Bio Recalls Homeopathic Sinus Relief for Microbial Contamination

King Bio Inc. is recalling Dr. King's Natural Medicine Homeopathic Sinus Relief 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 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 FDA classified this recall as Class I, which meets the rubric criteria for a Critical severity score.

Plain-English summary

King Bio Inc. is recalling 16,184 bottles of Dr. King's Natural Medicine Homeopathic Sinus Relief, 2 fl. oz. (59 mL). The recall was initiated due to microbial contamination. The product is identified by NDC 57955-5134-2 and UPC 357955513421.

The affected lots include 032217D (Exp. 03/20), 033116B (Exp. 03/19), 041518F (Exp. 04/20), 061715D (Exp. 06/18), 080116C (Exp. 08/19), 100417A (Exp. 10/19), and 121916A (Exp. 12/19). The product was distributed nationwide in the U.S.A., as well as in Canada and Australia.

Consumers should stop using the product 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 will cause serious adverse health consequences or death.

The recalled product

Product
Dr. King's Natural Medicine Homeopathic Sinus Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955513421, NDC 57955-5134-2
Manufacturer
King Bio Inc.
Category
Drug — Homeopathic Medicine
Hazard
Affected units
16,184

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 (7)

  • Lot Numbers: 032217D Exp. 03/20
  • 033116B Exp. 03/19
  • 041518F Exp. 04/20
  • 061715D Exp. 06/18
  • 080116C Exp. 08/19
  • 100417A Exp. 10/19
  • 121916A Exp. 12/19

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 →

Related recalls

Same manufacturer · King Bio Inc.

See all →

Same hazard · microbial contamination

See all →

Similar recalls