FDA action counts
| Total FDA actions | 5 |
|---|---|
| Warning letters | 1 |
| Recalls | 4 |
| Approval records | 0 |
| Form 483 inspection citations | 0 |
| Most recent action | July 16, 2026 |
Risk pattern analysis
Argus HQ analysis — not an FDA finding
This section is Argus HQ analysis, not an FDA finding. Island Kinetics, Inc. d.b.a. CoValence Laboratories has 4 separate FDA recalls on file, more than a single isolated recall event. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed.
Enforcement history
On 2026-04-22, Argus HQ recorded a FDA recall for Island Kinetics, Inc. d.b.a. CoValence Laboratories, rated "medium" severity in Argus HQ's classification: Island Kinetics, Inc. d.b.a. CoValence Laboratories — Class III recall: Essential Calming Skin Gel, hydrocortisone 1%, 120mL/4oz net wt. (113g) per jar,… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-04-22, Argus HQ recorded a FDA recall for Island Kinetics, Inc. d.b.a. CoValence Laboratories, rated "high" severity in Argus HQ's classification: Island Kinetics, Inc. d.b.a. CoValence Laboratories — Class II recall: Blemish Spot Treatment (Salicylic Acid) 1%, .5 fl oz (15 ml) bottles, Skin Scrip… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-04-22, Argus HQ recorded a FDA recall for Island Kinetics, Inc. d.b.a. CoValence Laboratories, rated "medium" severity in Argus HQ's classification: Island Kinetics, Inc. d.b.a. CoValence Laboratories — Class III recall: Skin Rehab, Calming Skin Gel, Hydrocortisone Balm, hydrocortisone 1%, .53oz net… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-04-22, Argus HQ recorded a FDA recall for Island Kinetics, Inc. d.b.a. CoValence Laboratories, rated "medium" severity in Argus HQ's classification: Island Kinetics, Inc. d.b.a. CoValence Laboratories — Class III recall: Remedy Gel, hydrocortisone 1%, 30 mL/ 1 fl oz per bottle, Distributed By: glo Sk… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. In total, Island Kinetics, Inc. d.b.a. CoValence Laboratories has 4 FDA events on file with Argus HQ across the sources Argus HQ currently tracks (FDA Warning Letters, recalls, drug/biologic approvals, and Form 483 inspection observations).
Frequently asked questions
- How many FDA actions does Argus HQ track for Island Kinetics, Inc. d.b.a. CoValence Laboratories?
- 5 total: 1 warning letter, 4 recalls, 0 approval records, and 0 Form 483 inspection citations.
- What is the most recent FDA action on file for Island Kinetics, Inc. d.b.a. CoValence Laboratories?
- July 16, 2026. Argus HQ ingests new FDA enforcement records daily.
- Has Island Kinetics, Inc. d.b.a. CoValence Laboratories received FDA warning letters?
- Yes, 1 warning letter on file. See the full history below for each one.
- Has Island Kinetics, Inc. d.b.a. CoValence Laboratories had product recalls?
- Yes, 4 recalls on file. See the full history below for each one.
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Related enforcement actions
- Island Kinetics, Inc. d.b.a. CoValence Laboratories — CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated (2026-07-16) →
- Island Kinetics, Inc. d.b.a. CoValence Laboratories — Class III recall: Skin Rehab, Calming Skin Gel, Hydrocortisone Balm, hydrocortisone 1%, .53oz net… →
- Island Kinetics, Inc. d.b.a. CoValence Laboratories — Class III recall: Essential Calming Skin Gel, hydrocortisone 1%, 120mL/4oz net wt. (113g) per jar,… →
- Island Kinetics, Inc. d.b.a. CoValence Laboratories — Class III recall: Remedy Gel, hydrocortisone 1%, 30 mL/ 1 fl oz per bottle, Distributed By: glo Sk… →
- Island Kinetics, Inc. d.b.a. CoValence Laboratories — Class II recall: Blemish Spot Treatment (Salicylic Acid) 1%, .5 fl oz (15 ml) bottles, Skin Scrip… →
Compare with
- Island Kinetics, Inc. d.b.a. CoValence Laboratories vs Philips North America
- Island Kinetics, Inc. d.b.a. CoValence Laboratories vs Medline Industries, LP
- Island Kinetics, Inc. d.b.a. CoValence Laboratories vs Boston Scientific Corporation
- Island Kinetics, Inc. d.b.a. CoValence Laboratories vs Baxter Healthcare Corporation
- Island Kinetics, Inc. d.b.a. CoValence Laboratories vs PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Two different companies merged onto this page by mistake? Or a name variant missing? Tell us — corrections@argushq.ai
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Verified from FDA.gov · Last updated: Jul 16, 2026Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). Island Kinetics, Inc. d.b.a. CoValence Laboratories's Complete FDA Record. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/company/island-kinetics-inc-d-b-a-covalence-laboratories
"Island Kinetics, Inc. d.b.a. CoValence Laboratories's Complete FDA Record." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/company/island-kinetics-inc-d-b-a-covalence-laboratories.
Argus HQ Research. "Island Kinetics, Inc. d.b.a. CoValence Laboratories's Complete FDA Record." Digital Empire Holdings LLC. Accessed August 27, 2026. https://argushq.ai/company/island-kinetics-inc-d-b-a-covalence-laboratories.
@misc{argushq_argushq_ai_company_island_kinetics_inc_d_b_a_covalence_laboratories_2026,
title = {Island Kinetics, Inc. d.b.a. CoValence Laboratories's Complete FDA Record},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/company/island-kinetics-inc-d-b-a-covalence-laboratories},
note = {Accessed: August 27, 2026}
}Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗

