FDA action counts
| Total FDA actions | 4 |
|---|---|
| Warning letters | 0 |
| Recalls | 4 |
| Approval records | 0 |
| Form 483 inspection citations | 0 |
| Most recent action | July 29, 2026 |
Enforcement history
On 2026-07-08, Argus HQ recorded an FDA recall for Asclemed USA Inc., rated "high" severity in Argus HQ's classification: Asclemed USA Inc. — Class II recall: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Di…. On 2026-07-08, Argus HQ recorded an FDA recall for Asclemed USA Inc., rated "high" severity in Argus HQ's classification: Asclemed USA Inc. — Class II recall: Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single…. On 2026-06-10, Argus HQ recorded an FDA recall for Asclemed USA Inc., rated "high" severity in Argus HQ's classification: Asclemed USA Inc. — Class II recall: Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pha…. 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. 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. 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. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.
Risk pattern analysis
Argus HQ analysis — not an FDA finding
This section is Argus HQ analysis, not an FDA finding. Asclemed USA Inc. has 3 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. Argus HQ does not independently verify FDA's underlying findings; this page summarizes what FDA has published and links back to the original FDA source for each event. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.
Frequently asked questions
- Does Argus HQ track new FDA actions for Asclemed USA Inc. automatically?
- Yes. Argus HQ ingests FDA sources daily, including FDA warning letters, recalls, drug and biologic approvals, and Form 483 inspection observations. When a new FDA action linked to Asclemed USA Inc. is observed, this page's event count and history update automatically.
- How many FDA actions does Argus HQ track for Asclemed USA Inc.?
- 4 total: 0 warning letters, 4 recalls, 0 approval records, and 0 Form 483 inspection citations.
- What is the most recent FDA action on file for Asclemed USA Inc.?
- July 29, 2026. Argus HQ ingests new FDA enforcement records daily.
- Has Asclemed USA Inc. had product recalls?
- Yes, 4 recalls on file. See the full history below for each one.
Every FDA action tied to this company, the week it happens.
Free weekly briefing. Real-time alerts on paid plans.
Related enforcement actions
- Asclemed USA Inc. — Class III recall: Lidolog Kit, Kit Contains: Lidocaine HCl Injection, USP, 2% (2mL) vial, 1 Dose,… →
- Asclemed USA Inc. — Class II recall: Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single… →
- Asclemed USA Inc. — Class II recall: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Di… →
- Asclemed USA Inc. — Class II recall: Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pha… →
Compare with
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 29, 2026Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). FDA Enforcement History: Asclemed USA Inc.. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/company/asclemed-usa-inc
"FDA Enforcement History: Asclemed USA Inc.." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/company/asclemed-usa-inc.
Argus HQ Research. "FDA Enforcement History: Asclemed USA Inc.." Digital Empire Holdings LLC. Accessed August 27, 2026. https://argushq.ai/company/asclemed-usa-inc.
@misc{argushq_argushq_ai_company_asclemed_usa_inc_2026,
title = {FDA Enforcement History: Asclemed USA Inc.},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/company/asclemed-usa-inc},
note = {Accessed: August 27, 2026}
}Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗