CLASS II Drug recall · Reported 27 Jan 2016 · FDA Enforcement Report
Energique, Homeopathic Remedy recalled by Grato Holdings
Grato Holdings is recalling Energique, Homeopathic Remedy, Headache Pain & Sinus Pressure Relief, Topical Spray, distributed nationwide in the US. The recall was initiated on 22 Dec 2015 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-0579-2016
- FDA event ID
- 72891
- Recalling firm
- Grato Holdings, Woodbine, IA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Dec 2015
- FDA classified
- 20 Jan 2016
- Reported
- 27 Jan 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Creams, Ointments & Gels
Timeline
| 22 Dec 2015 | Recall initiated by company | |
| 20 Jan 2016 | Classified by FDA | +29 days |
| 27 Jan 2016 | Published in enforcement report | +7 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; testing revealed out of specification results for total aerobic microbiological count
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
Energique, Homeopathic Remedy, Headache Pain & Sinus Pressure Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0134-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, Headache Pain & Sinus Pressure Relief, Topical Homeopathic Spray, NDC 50845-0217-1, Dist By Liddell Laboratories, Inc., Woodbine, IA 51579; and peaceful mountain, Headache Pain & Sinus Pressure Relief, homeopathic spray, UPC 8 18692 00885 9, NDC 43846-0041-1, Dist. by Peaceful Mountain, Inc. Woodbine, IA
Where it was distributed
Nationwide and to Guatemala and Canada.
Questions about this recall
Why was it recalled?
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Which lots are affected?
Lot: G9471
Where was it sold?
Nationwide and to Guatemala and Canada.
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 72891This product is part of a recall event; the main page for the event is Energique, Homeopathic Remedy recalled by Grato Holdings.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Energique, Homeopathic Remedy recalled by Grato Holdings | Grato Holdings | Sterility | Nationwide | |
| CLASS II | Energique, Homeopathic Remedy recalled by Grato Holdings | Grato Holdings | Sterility | Nationwide | |
| CLASS II | Energique, Homeopathic Remedy recalled by Grato Holdings | Grato Holdings | Sterility | Nationwide | |
| CLASS II | Energique, Homeopathic Remedy, First Aid Pain & Trauma Relief recalled | Grato Holdings | Sterility | Nationwide | |
| CLASS II | Energique, Homeopathic Remedy recalled by Grato Holdings | Grato Holdings | Sterility | Nationwide |
More recalls from Grato Holdings
All 18| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Food | CLASS II | BioActive Nutritional Minaplex, Botanical Herbal Supplement recalledBioActive Nutritional | Grato Holdings | Mold | Nationwide |
| Food | CLASS II | Energique Mineral Magic Dietary Supplement recalled by Grato HoldingsEnergique Mineral | Grato Holdings | Mold | Nationwide |
| Drug | CLASS III | V-force Homeopathic recalled by Grato Holdings | Grato Holdings | Packaging Defects | FL |
| Drug | CLASS II | Earache Drops recalled by Grato HoldingsWalgreens Earache Drops | Grato Holdings | Sterility | Nationwide |
| Drug | CLASS II | Homeopathic EarAche Ear Drops recalled by Grato Holdings | Grato Holdings | Sterility | Nationwide |
Other Energique recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Energique, Homeopathic Remedy recalled by Grato Holdings | Grato Holdings | Sterility | Nationwide |
| Drug | CLASS II | Energique, Homeopathic Remedy recalled by Grato Holdings | Grato Holdings | Sterility | Nationwide |
| Drug | CLASS II | Energique, Homeopathic Remedy recalled by Grato Holdings | Grato Holdings | Sterility | Nationwide |
| Drug | CLASS II | Energique, Homeopathic Remedy recalled by Grato Holdings | Grato Holdings | Sterility | Nationwide |