Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported September 24, 2014
Dermatend Original, mole, wart and skin tag remover, For external use only, Ingredient: Distilled Water, Sanguinaria Canadensis, Vegetable Glycerin, Butter of Zinc, Germall Plus, 0.17 OZ (5g) container, Solace International, Inc., Reno, NV 89509, USA
Labeling: Labeling Bears Unapproved Claims; Dermatend is not FDA approved and therefore has not been shown to be safe and effective for the uses suggested in the labeling.
Solace International Inc recalled Dermatend Original, mole, wart and skin tag remover, For external use only, Ingredient: D… - a moderate-severity action.
Dermatend Original, mole, wart and skin tag remover, For external use only, Ingredient: D… was recalled by Solace International Inc in September 24, 2014. Reason: Labeling: Labeling Bears Unapproved Claims; Dermatend is not FDA approved and therefore has not been shown to…. Check the official notice for the remedy. Verify recall #D-1585-2014 with the FDA Drug before acting.
The recall
Solace International Inc issued this moderate-severity FDA Drug recall-Labeling: Labeling Bears Unapproved Claims; Dermatend is not FDA approved and therefore has not been shown to….
- Moderate
- severity level
- Class II
- classification
- September 24, 2014
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-1585-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-1585-2014) was formally reported on September 24, 2014, with the manufacturer initiating the action on August 28, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Solace International Inc is listed as the recalling firm, operating out of Reno, NV. Federal records list the affected scope as 1606 containers.
The documented reason for this recall is: Labeling: Labeling Bears Unapproved Claims; Dermatend is not FDA approved and therefore has not been shown to be safe and effective for the uses suggested in the labeling. Distribution data in the federal record shows the product reached: Amazon US and Amazon UK. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Food recalls over time
Where this recall sits in its category - 25,126 food recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1606 containers
Related Recalls
6
0 from same agency
Product description
Dermatend Original, mole, wart and skin tag remover, For external use only, Ingredient: Distilled Water, Sanguinaria Canadensis, Vegetable Glycerin, Butter of Zinc, Germall Plus, 0.17 OZ (5g) container, Solace International, Inc., Reno, NV 89509, USA
Reason for recall
Labeling: Labeling Bears Unapproved Claims; Dermatend is not FDA approved and therefore has not been shown to be safe and effective for the uses suggested in the labeling.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-1585-2014 |
| Date reported | September 24, 2014 |
| Date initiated | August 28, 2014 |
| Recalling firm | Solace International Inc |
| Firm location | Reno, NV |
| Affected scope | 1606 containers |
| Distribution | Amazon US and Amazon UK |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-1585-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Dermatend Original, mole, wart and skin tag remover, For external use only, Ingredient: Distilled Water, Sanguinaria Canadensis, Vegetable Glycerin, Butter of Zinc, Germall Plus, 0.17 OZ (5g) container, Solace International, Inc., Reno, NV 89509, USA. Recalled by Solace International Inc. Units affected: 1606 containers.
Why was this product recalled? ▼
Labeling: Labeling Bears Unapproved Claims; Dermatend is not FDA approved and therefore has not been shown to be safe and effective for the uses suggested in the labeling.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 24, 2014. Severity: Moderate. Recall number: D-1585-2014.
Where was the recalled product distributed? ▼
Distribution: Amazon US and Amazon UK.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-1585-2014) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported September 24, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.