Has Teva Pharmaceuticals USA, Inc had other FDA enforcement actions?

Yes. Argus HQ has recorded 41 total FDA actions tied to Teva Pharmaceuticals USA, Inc: 0 warning letters, 39 recalls, 2 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 2024-07-24; Argus observed and indexed it on 2026-07-16.

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

Teva Pharmaceuticals USA, Inc — Class II recall: Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 100 Tablets per bottle, Man…

Name: FDA Recall Record — Teva Pharmaceuticals USA, Inc
Creator: Argus HQ
Published: 2024-07-24
License: https://argushq.ai/methodology

Event date: 2024-07-24 00:00:00Z
Observed: 2026-07-16 23:20:07Z
Source ID: D-0601-2024
Payload hash: 1c53e4bb6d6bf0d39f33913d…

Summary

Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits. Status: Ongoing.

Entities

Teva Pharmaceuticals USA, Inc

View source record ↗

Frequently asked questions

Has Teva Pharmaceuticals USA, Inc had other FDA enforcement actions?: Yes. Argus HQ has recorded 41 total FDA actions tied to Teva Pharmaceuticals USA, Inc: 0 warning letters, 39 recalls, 2 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 2024-07-24; Argus observed and indexed it on 2026-07-16.
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 (2024). Teva Pharmaceuticals USA, Inc — Class II recall: Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 100 Tablets per bottle, Man…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-teva-pharmaceuticals-usa-inc-d-0601-2024

MLA

"Teva Pharmaceuticals USA, Inc — Class II recall: Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 100 Tablets per bottle, Man…." Argus HQ Research, Digital Empire Holdings LLC, 2024, argushq.ai/events/fda-recall-teva-pharmaceuticals-usa-inc-d-0601-2024.

Chicago

Argus HQ Research. "Teva Pharmaceuticals USA, Inc — Class II recall: Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 100 Tablets per bottle, Man…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-teva-pharmaceuticals-usa-inc-d-0601-2024.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_teva_pharmaceuticals_usa_inc_d_0601_2024_2024,
  title = {Teva Pharmaceuticals USA, Inc — Class II recall: Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 100 Tablets per bottle, Man…},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-teva-pharmaceuticals-usa-inc-d-0601-2024},
  note = {Accessed: July 23, 2026}
}

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