The Recall Desk
CriticalFDA (Drugs)·D-0749-2019·Announced 2019-03-20

King Bio Recalls Cold Sore Cream Due to Microbial Contamination

King Bio Inc. is recalling Dr. King's SafeCare Rx Cold Sores & Herpes Skin cream 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 FDA has classified this recall as Class I, which per the rubric mandates a severity score of 5 (Critical) due to the potential for serious adverse health consequences.

Plain-English summary

King Bio Inc. is recalling Dr. King's SafeCare Rx Cold Sores & Herpes Skin, 2 fl. oz. (59 mL), due to microbial contamination. The recall involves 783 bottles of the product, identified by NDC 57955-0165-2 and UPC 357955016526.

The affected lots are 032216D (Exp. 03/19), 072815G (Exp. 07/18), and 022017A (Exp. 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 check their lot numbers against the list provided. The FDA has classified this as a Class I recall, indicating 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 Cold Sores & Herpes Skin, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955016526, NDC 57955-0165-2
Manufacturer
King Bio Inc.
Category
Drug — Topical Antiviral
Hazard
Affected units
783

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: 032216D Exp. 03/19
  • 072815G Exp. 07/18
  • 022017A 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 →

Related recalls

Same manufacturer · King Bio Inc.

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Same hazard · microbial contamination

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