The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0837-2019·Announced 2019-03-20

King Bio Recalls Dr. King's SafeCare Rx Hair & Nails Formula

King Bio Inc. is recalling Dr. King's SafeCare Rx Hair & Nails Formula 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 has classified this recall as Class I, which meets the rubric criteria for a Critical severity score.

Plain-English summary

King Bio Inc. is voluntarily recalling 230 bottles of Dr. King's SafeCare Rx Hair & Nails Formula, 2 fl. oz. (59 mL). The recall is due to microbial contamination. The product is identified by NDC 57955-0049-2 and UPC 357955004929.

The affected lots are 072015F (Exp. 07/18), 062816E (Exp. 06/19), and 100316E (Exp. 10/19). The product was distributed nationwide in the United States, as well as in Canada and Australia.

Consumers should stop using the product and check their lot numbers against the list above. The FDA has classified this recall as Class I, 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 Hair & Nails Formula, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955004929, NDC 57955-0049-2
Manufacturer
King Bio Inc.
Category
Drug — Topical
Hazard
Affected units
230

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: 072015F Exp. 07/18
  • 062816E Exp. 06/19
  • 100316E Exp. 10/19

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