CLASS II Drug recall · Reported 7 Nov 2018 · FDA Enforcement Report
Arnica Power, Homeopathic Oral Spray recalled by Sprayology
Sprayology is recalling Arnica Power, Homeopathic Oral Spray, distributed nationwide in the US. The recall was initiated on 9 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-0117-2019
- FDA event ID
- 81218
- Recalling firm
- Sprayology, Gaithersburg, MD
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Oct 2018
- FDA classified
- 30 Oct 2018
- Reported
- 7 Nov 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Sterility
Timeline
| 9 Oct 2018 | Recall initiated by company | |
| 30 Oct 2018 | Classified by FDA | +21 days |
| 7 Nov 2018 | Published in enforcement report | +8 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
Arnica Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879.NDC 61096-0032-1
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Is Arnica Power, Homeopathic Oral Spray recalled?
Yes. Sprayology recalled Arnica Power, Homeopathic Oral Spray on 9 Oct 2018. The recall is Class II and its status is Terminated. Recall number D-0117-2019.
Why was it recalled?
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Which lots are affected?
All lots within expiry
Where was it sold?
Distributed Nationwide in the 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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Sprayology
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Bone Builder, Homeopathic Oral Spray recalled by Sprayology | Sprayology | Sterility | Nationwide |
| Drug | CLASS II | Man Power, Homeopathic Oral Spray recalled by Sprayology | Sprayology | Sterility | Nationwide |
| Drug | CLASS II | ImmunoBooster, Homeopathic Oral Spray recalled by Sprayology | Sprayology | Sterility | Nationwide |
| Drug | CLASS II | PMS Support, Homeopathic Oral Spray recalled by Sprayology | Sprayology | Sterility | Nationwide |
| Drug | CLASS II | Body Balance, Homeopathic Oral Spray recalled by Sprayology | Sprayology | Sterility | Nationwide |