The Recall Desk
CriticalFDA (Drugs)·D-0710-2019·Announced 2019-03-20

King Bio Recalls Dr. King's SafeCare Rx Stye Free Eye Drops

King Bio Inc. is recalling 126 bottles of Dr. King's SafeCare Rx Stye Free eye drops 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 source text explicitly identifies the agency classification as 'Class I'. According to the severity rubric, an FDA Class I recall mandates a score of 5 (Critical) because it indicates a reasonable probability of serious adverse health consequences or death.

Plain-English summary

King Bio Inc. is recalling 126 bottles of Dr. King's SafeCare Rx Stye Free eye drops, 2 fl. oz. (59 mL), due to microbial contamination. The affected product is identified by NDC 57955-0132-2 and UPC 357955012528.

The recall covers specific lots with the following expiration dates: 08/18 (Lot 083115B), 06/19 (Lot 061716A), 12/19 (Lot 120516B), and 01/20 (Lot 010418F). 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 inventory for the listed lot numbers and expiration dates. 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 Stye Freee..., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955012528, NDC 57955-0132-2
Manufacturer
King Bio Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
126

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 (4)

  • Lots: 083115B Exp. 08/18
  • 061716A Exp. 06/19
  • 120516B Exp. 12/19
  • 010418F Exp. 01/20

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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