The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0662-2019·Announced 2019-03-20

King Bio Recalls Dr. King's Baby Colic Relief Due to Microbial Contamination

King Bio Inc. is recalling Dr. King's Baby Colic Relief Homeopathic due to microbial contamination. Consumers should stop using the product and return it to the place of purchase.

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 has classified this recall as Class I, which per the rubric mandates a severity score of 5 (Critical) regardless of other factors.

Plain-English summary

King Bio Inc. is recalling 257 bottles of Dr. King's Baby Colic Relief Homeopathic, 2 fl. oz. (59 mL), due to microbial contamination. The product is identified by NDC 57955-0466-2 and UPC 357955515821. The affected lots are 020118H (Expiration 02/2020) and 092017A (Expiration 09/2019).

The recall covers distribution in the U.S.A. Nationwide, Canada, and Australia. 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.

Consumers should stop using the product immediately and return it to the place of purchase for a refund. For more information, contact King Bio Inc. at 3 Westside Dr. Asheville, NC 28806 USA.

The recalled product

Product
Dr. King's Baby Colic Relief Homeopathic, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955515821, NDC 57955-0466-2
Manufacturer
King Bio Inc.
Category
Drug — Homeopathic
Hazard
Affected units
257

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 (2)

  • Lots: 020118H Exp. 02/2020
  • 092017A Exp. 09/2019

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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