CLASS I Drug recall · Reported 14 Nov 2018 · FDA Enforcement Report

Native Remedies VaricoGo Oral Spray recalled by Silver Star Brands

Silver Star Brands is recalling Native Remedies VaricoGo Oral Spray per, distributed nationwide in the US. The recall was initiated on 3 Oct 2018 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesLot K111717A
Quantity recalled53 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number
D-0253-2019
FDA event ID
81228
Recalling firm
Silver Star Brands, Oshkosh, WI
Classification
Class I
Status
Terminated
Recall initiated
3 Oct 2018
FDA classified
19 Nov 2018
Reported
14 Nov 2018
Type
Voluntary: Firm initiated
Customers notified by
Press Release
Reason category
Sterility

Timeline

3 Oct 2018Recall initiated by company
14 Nov 2018Published in enforcement report+42 days
19 Nov 2018Classified by FDA+5 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Microbial Contamination of Non-Sterile Products

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Native Remedies VaricoGo Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-105-59

Where it was distributed

Nationwide USA

Nationwide

Questions about this recall

Why was it recalled?

Microbial Contamination of Non-Sterile Products

Which lots are affected?

Lot K111717A

Where was it sold?

Nationwide USA

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

5 other products · FDA event 81228

More recalls from Silver Star Brands

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