The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0740-2019·Announced 2019-03-20

FDA Recalls Dr. King's SafeCare Rx Better Breath Due to Microbial Contamination

King Bio Inc. is recalling Dr. King's SafeCare Rx Better Breath Oral Health 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 Dr. King's SafeCare Rx Better Breath Oral Health, 2 fl. oz. (59 mL), due to microbial contamination. The recall involves 12 bottles per unit, identified by UPC 357955630128 and NDC 57955-6302-2.

The affected lots are 060116G (Expiration 06/19) and 020817F (Expiration 02/20). The product was distributed nationwide in the United States, as well as in Canada and Australia.

Consumers should stop using the product and contact King Bio Inc. for further instructions or a refund.

The recalled product

Product
Dr. King's SafeCare Rx Better Breath Oral Health, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955630128, NDC 57955-6302-2
Manufacturer
King Bio Inc.
Category
Drug — Oral Health
Hazard
Affected units
12

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: 060116G Exp. 06/19
  • 020817F Exp. 02/20

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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