CLASS II Drug recall · Reported 14 Nov 2018 · FDA Enforcement Report
Healthful Naturals Leg Cramp Support Oral Spray recalled
Silver Star Brands is recalling Healthful Naturals Leg Cramp Support Oral Spray per, distributed nationwide in the US. The recall was initiated on 3 Oct 2018 and the FDA has classified it as Class II.
Check your package
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-0256-2019
- FDA event ID
- 81228
- Recalling firm
- Silver Star Brands, Oshkosh, WI
- Classification
- Class II
- 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 2018 | Recall initiated by company | |
| 14 Nov 2018 | Published in enforcement report | +42 days |
| 19 Nov 2018 | Classified 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
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
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
Healthful Naturals Leg Cramp Support Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906 NDC 68703-206-02
Where it was distributed
Nationwide USA
Questions about this recall
Why was it recalled?
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Which lots are affected?
Lot K022216C
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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 81228This product is part of a recall event; the main page for the event is Native Remedies VaricoGo Oral Spray recalled by Silver Star Brands.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Native Remedies VaricoGo Oral Spray recalled by Silver Star Brands | Silver Star Brands | Sterility | Nationwide | |
| CLASS I | Native Remedies HypoSlim Oral Spray recalled by Silver Star Brands | Silver Star Brands | Sterility | Nationwide | |
| CLASS I | Native Remedies Eye recalled by Silver Star Brands | Silver Star Brands | Sterility | Nationwide | |
| CLASS II | Healthful Naturals DizziFree Oral Spray recalled by Silver Star Brands | Silver Star Brands | Sterility | Nationwide | |
| CLASS I | Native Remedies VertiFree Oral Spray recalled by Silver Star Brands | Silver Star Brands | Sterility | Nationwide |
More recalls from Silver Star Brands
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Native Remedies VertiFree Oral Spray recalled by Silver Star Brands | Silver Star Brands | Sterility | Nationwide |
| Drug | CLASS II | Healthful Naturals DizziFree Oral Spray recalled by Silver Star Brands | Silver Star Brands | Sterility | Nationwide |
| Drug | CLASS I | Native Remedies Eye recalled by Silver Star Brands | Silver Star Brands | Sterility | Nationwide |
| Drug | CLASS I | Native Remedies HypoSlim Oral Spray recalled by Silver Star Brands | Silver Star Brands | Sterility | Nationwide |
| Drug | CLASS I | Native Remedies VaricoGo Oral Spray recalled by Silver Star Brands | Silver Star Brands | Sterility | Nationwide |