Has Asclemed USA Inc. had other FDA enforcement actions?

Yes. Argus HQ has recorded 3 total FDA actions tied to Asclemed USA Inc.: 0 warning letters, 3 recalls, 0 approval records, and 0 Form 483 inspection citations.

What kind of FDA record is this?

This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2026-07-08; Argus observed and indexed it on 2026-07-14.

Where can I verify this record directly with FDA?

The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

.hq

fda_recall · drug_recall · high

Asclemed USA Inc. — Class II recall: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Di…

Name: FDA Recall Record — Asclemed USA Inc.
Creator: Argus HQ
Published: 2026-07-08
License: https://argushq.ai/methodology

Event date: 2026-07-08 00:00:00Z
Observed: 2026-07-14 04:20:18Z
Source ID: D-0659-2026
Payload hash: a211cf6cd016877ce6c9ece6…

Summary

Lack of Assurance of Sterility Status: Ongoing.

Entities

Asclemed USA Inc.

View source record ↗

Frequently asked questions

Has Asclemed USA Inc. had other FDA enforcement actions?: Yes. Argus HQ has recorded 3 total FDA actions tied to Asclemed USA Inc.: 0 warning letters, 3 recalls, 0 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?: This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2026-07-08; Argus observed and indexed it on 2026-07-14.
Where can I verify this record directly with FDA?: The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). Asclemed USA Inc. — Class II recall: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Di…. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-asclemed-usa-inc-d-0659-2026

MLA

"Asclemed USA Inc. — Class II recall: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Di…." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/events/fda-recall-asclemed-usa-inc-d-0659-2026.

Chicago

Argus HQ Research. "Asclemed USA Inc. — Class II recall: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Di…." Digital Empire LLC. Accessed July 14, 2026. https://argushq.ai/events/fda-recall-asclemed-usa-inc-d-0659-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_asclemed_usa_inc_d_0659_2026_2026,
  title = {Asclemed USA Inc. — Class II recall: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Di…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-asclemed-usa-inc-d-0659-2026},
  note = {Accessed: July 14, 2026}
}

Informational only. Not legal, financial, or medical advice.