The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0808-2019·Announced 2019-03-20

Recall of Dr. King's SafeCare Rx Insecurity due to microbial contamination

The FDA is recalling Dr. King's SafeCare Rx Insecurity because of microbial contamination found in the product.

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 according to the source metadata, which mandates a minimum severity score of 4 per the rubric. Additionally, the recall reason involves microbial contamination—a serious health hazard—further supporting a high severity rating.

Plain-English summary

The U.S. Food and Drug Administration is recalling Dr. King's SafeCare Rx Insecurity, a 2 fl. oz. prescription medication produced by King Bio Inc., due to the discovery of microbial contamination. This recall affects specific lots (042116A and 072216N) with expiration dates of April 19 and July 19, 2019, distributed across the United States, Canada, and Australia. Consumers are strongly advised to discontinue use of this product immediately and contact their healthcare provider for guidance. The recall is classified as FDA Class I, indicating a serious safety concern that requires prompt consumer action.

Microbial contamination represents a direct health risk as it can lead to infection or adverse reactions depending on the nature of the contaminant. Because the product is a prescription medication and the agency has designated this as a Class I recall, the situation warrants a higher severity rating. The presence of microbial contamination in a drug product falls under the rubric's requirement for at least a severity score of 4 when combined with a Class I classification.

Consumers should not consume the recalled product and should seek medical attention if they experience any symptoms following exposure. The recall covers multiple lots with different expiration dates, and the manufacturer King Bio Inc. is responsible for issuing corrective actions such as product replacement or refund. All affected consumers are urged to follow the FDA's recommendations and report any adverse events to local health authorities.

The recalled product

Product
Dr. King's SafeCare Rx Insecurity, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955256021, NDC 57955-2561-2
Manufacturer
King Bio Inc.
Category
Drug — prescription medication
Hazard
Affected units
70

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: 042116A Exp. 04/19
  • 072216N 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 →

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