The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0598-2019·Announced 2019-03-20

King Bio Homeopathic Sleep Aid Recalled for Microbial Contamination

King Bio Inc. is recalling Dr. King's Natural Medicine Homeopathic Sleep Aid 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 score of 4 or higher.

Plain-English summary

King Bio Inc. is recalling 18,449 bottles of Dr. King's Natural Medicine Homeopathic Sleep Aid, 2 fl. oz. (59 mL). The recall is being conducted due to microbial contamination. The product is identified by NDC 57955-5839-2 and UPC 357955503927.

The affected lots include 021016E, 060118C, 060518A, 071318G, 080717A, 081315N, 111516J, 122017A, and 122915D. These products were distributed nationwide in the United States, as well as in Canada and Australia.

Consumers should stop using the product and return it to the place of purchase for a refund or contact the manufacturer for further instructions.

The recalled product

Product
Dr. King's Natural Medicine Homeopathic Sleep Aid, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955503927, NDC 57955-5839-2
Manufacturer
King Bio Inc.
Category
Drug — Homeopathic
Hazard
Affected units
18,449

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 (9)

  • Lots: 021016E Exp. 02/19
  • 060118C Exp. 06/20
  • 060518A Exp. 06/20
  • 071318G Exp. 07/20
  • 080717A Exp. 08/19
  • 081315N Exp. 08/18
  • 111516J Exp. 11/19
  • 122017A Exp. 12/2019
  • 122915D Exp. 12/18

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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