The Recall Desk
CriticalFDA (Drugs)·D-0854-2019·Announced 2019-03-20

King Bio Recalls Dr. King's SafeCare Rx Heartache Due to Microbial Contamination

King Bio Inc. is recalling Dr. King's SafeCare Rx Heartache due to microbial contamination. The product was distributed in the U.S., Canada, and Australia.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

King Bio Inc. is recalling 153 bottles of Dr. King's SafeCare Rx Heartache, 2 fl. oz. (59 mL). The recall is being conducted due to microbial contamination. The affected product is identified by NDC 57955-2030-2 and UPC 357955203025.

The recalled product was distributed nationwide in the United States, as well as in Canada and Australia. Specific lots affected include 082015A (Expiration 08/18) and 072516F (Expiration 07/19).

Consumers should check their inventory for the specific lot numbers and expiration dates listed above. If you have this product, you should stop using it and contact King Bio Inc. for further instructions or a refund.

The recalled product

Product
Dr. King's SafeCare Rx Heartache, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955203025, NDC 57955-2030-2
Manufacturer
King Bio Inc.
Affected units
153

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: 082015A Exp. 08/18
  • 072516F Exp. 07/19

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 →