The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0754-2019·Announced 2019-03-20

King Bio Recalls Constitutional Enhancer Due to Microbial Contamination

King Bio Inc. is recalling Dr. King's SafeCare Rx Constitutional Enhancer 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 recall is classified as FDA Class I, which per the rubric mandates a severity score of 5 (Critical) due to the reasonable probability of serious adverse health consequences.

Plain-English summary

King Bio Inc. is voluntarily recalling Dr. King's SafeCare Rx Constitutional Enhancer, a 2 fl. oz. (59 mL) liquid product, due to microbial contamination. The recall involves 794 bottles with specific lot numbers and expiration dates ranging from February 2019 to October 2019.

The affected product was distributed nationwide in the United States, as well as in Canada and Australia. The recall is classified as FDA Class I, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.

Consumers who have purchased this product should stop using it immediately and contact King Bio Inc. for further instructions or a refund. The product is identified by NDC 57955-0149-2 and UPC 357955014928.

The recalled product

Product
Dr. King's SafeCare Rx Constitutional Enhancer Constitution, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955014928, NDC 57955-0149-2
Manufacturer
King Bio Inc.
Category
Drug — Liquid Supplement
Hazard
Affected units
794

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 (3)

  • Lots: 102016F Exp. 10/19
  • 022316D Exp. 02/19
  • 061716D Exp. 06/19

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