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 2023-03-15; 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: Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, RX o…

Name: FDA Recall Record — Teva Pharmaceuticals USA, Inc
Creator: Argus HQ
Published: 2023-03-15
License: https://argushq.ai/methodology

Event date: 2023-03-15 00:00:00Z
Observed: 2026-07-16 23:20:07Z
Source ID: D-0441-2023
Payload hash: 84f7c3e83c74ab9a91d15258…

Summary

CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit. Status: Terminated.

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 2023-03-15; 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 (2023). Teva Pharmaceuticals USA Inc — Class II recall: Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, RX o…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-teva-pharmaceuticals-usa-inc-d-0441-2023

MLA

"Teva Pharmaceuticals USA Inc — Class II recall: Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, RX o…." Argus HQ Research, Digital Empire Holdings LLC, 2023, argushq.ai/events/fda-recall-teva-pharmaceuticals-usa-inc-d-0441-2023.

Chicago

Argus HQ Research. "Teva Pharmaceuticals USA Inc — Class II recall: Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, RX o…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-teva-pharmaceuticals-usa-inc-d-0441-2023.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_teva_pharmaceuticals_usa_inc_d_0441_2023_2023,
  title = {Teva Pharmaceuticals USA Inc — Class II recall: Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, RX o…},
  author = {{Argus HQ Research}},
  year = {2023},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-teva-pharmaceuticals-usa-inc-d-0441-2023},
  note = {Accessed: July 23, 2026}
}

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