The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0861-2019·Announced 2019-03-20

FDA Recalls Dr. King's Eye Drops Due to Microbial Contamination

King Bio Inc. is recalling Dr. King's SafeCare Rx Allergy & Red Eye Relief eye drops due to microbial contamination. The affected products were 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 agency classification is FDA Class I, which per the rubric mandates a severity score of 5 (Critical) as it indicates a reasonable probability of serious adverse health consequences or death.

Plain-English summary

King Bio Inc. is recalling 288 bottles of Dr. King's SafeCare Rx Allergy & Red Eye Relief, 2 fl. oz. (59 mL), due to microbial contamination. The product is identified by NDC 57955-0164-2 and UPC 357955016427.

The recall covers specific lots: 072816B (Expiration 07/19) and 080315B (Expiration 08/18). These products were distributed nationwide in the United States, as well as in Canada and Australia.

Consumers should stop using the affected eye drops and check their lot numbers and expiration dates against the information provided. The FDA has classified this as a Class I recall, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.

The recalled product

Product
Dr. King's SafeCare Rx Allergy & Red Eye Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955016427, NDC 57955-0164-2
Manufacturer
King Bio Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
288

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: 072816B Exp. 07/19
  • 080315B Exp. 08/18

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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