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fda_recall · drug_recall · high

Blaine Labs Inc — Class II recall: TERPENICOL Antifungal Cream (Undecylenic Acid 13%), 1.0 oz (28 g) bottles, Manuf…

Event date
2026-07-08 00:00:00Z
Observed
2026-07-23 04:20:36Z
Source ID
D-0695-2026
Payload hash
e34b14aa0a4d8036edde8b7d

Summary

CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry Status: Ongoing.

Frequently asked questions

Has Blaine Labs Inc had other FDA enforcement actions?
Yes. Argus HQ has recorded 8 total FDA actions tied to Blaine Labs Inc: 0 warning letters, 8 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 2026-07-23.
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). Blaine Labs Inc — Class II recall: TERPENICOL Antifungal Cream (Undecylenic Acid 13%), 1.0 oz (28 g) bottles, Manuf…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-blaine-labs-inc-d-0695-2026
MLA
"Blaine Labs Inc — Class II recall: TERPENICOL Antifungal Cream (Undecylenic Acid 13%), 1.0 oz (28 g) bottles, Manuf…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-blaine-labs-inc-d-0695-2026.
Chicago
Argus HQ Research. "Blaine Labs Inc — Class II recall: TERPENICOL Antifungal Cream (Undecylenic Acid 13%), 1.0 oz (28 g) bottles, Manuf…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-blaine-labs-inc-d-0695-2026.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_blaine_labs_inc_d_0695_2026_2026,
  title = {Blaine Labs Inc — Class II recall: TERPENICOL Antifungal Cream (Undecylenic Acid 13%), 1.0 oz (28 g) bottles, Manuf…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-blaine-labs-inc-d-0695-2026},
  note = {Accessed: July 23, 2026}
}

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