The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0251-2019·Announced 2018-11-14

Native Remedies VertiFree Oral Spray Recalled for Microbial Contamination

Silver Star Brands is recalling Native Remedies VertiFree Oral Spray due to microbial contamination. Consumers should stop using the product and return it to the point of purchase.

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 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

Silver Star Brands is voluntarily recalling 67 bottles of Native Remedies VertiFree Oral Spray, 2 fl oz (59 mL) per bottle, distributed nationwide in the United States. The recall is due to microbial contamination of the non-sterile product. The affected product is identified by Lot K061417B and NDC 68703-253-02.

The FDA has classified this recall as Class I, which is the most serious type of recall. This classification indicates a reasonable probability that the use of, or exposure to, the violative product may cause serious adverse health consequences or death.

Consumers who have purchased this product should stop using it immediately. They should return the product to the place of purchase for a refund or contact Silver Star Brands for further instructions.

The recalled product

Product
Native Remedies VertiFree Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-253-02
Manufacturer
Silver Star Brands
Category
Drug — Oral Spray
Hazard
Affected units
67

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 (1)

  • Lot K061417B

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Silver Star Brands 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 6 products in this recall →

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