The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0706-2019·Announced 2019-03-20

FDA Recalls King Bio Anxiety Product Due to Microbial Contamination

King Bio Inc. is recalling Dr. King's SafeCare Rx Intense Anxiety Mind & Body 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 source text explicitly identifies the agency classification as 'Class I', which corresponds to a Critical severity score of 5 according to the rubric.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class I recall for Dr. King's SafeCare Rx Intense Anxiety Mind & Body, 2 fl. oz. (59 mL), manufactured by King Bio Inc. The recall is due to microbial contamination. The affected product is identified by NDC 57955-1751-2 and UPC 357955175025.

The recall covers 4,405 bottles distributed nationwide in the United States, as well as in Canada and Australia. Specific lots affected include 073015A (Exp. 07/18), 123115F (Exp. 12/18), 060916A (Exp. 06/19), 042717A (Exp. 04/20), and 010118Y (Exp. 01/20).

Consumers should stop using the product and contact King Bio Inc. for further instructions or a refund. The FDA classifies this as a Class I recall, which indicates a reasonable probability that use of the product may cause serious adverse health consequences or death.

The recalled product

Product
Dr. King's SafeCare Rx Intense Anxiety Mind & Body, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955175025, NDC 57955-1751-2
Manufacturer
King Bio Inc.
Category
Drug — Supplement
Hazard
Affected units
4,405

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)

  • Lots: 073015A Exp. 07/18
  • 123115F Exp. 12/18
  • 060916A Exp. 06/19
  • 042717A Exp. 04/20
  • 010118Y Exp. 01/20

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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