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fda_recall · drug_recall · high

Teva Pharmaceuticals USA Inc — Class II recall: Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By:…

Event date
2023-07-19 00:00:00Z
Observed
2026-07-16 23:20:07Z
Source ID
D-0913-2023
Payload hash
b8f02453148121cbdba0b8ec…

Summary

Failed Moisture Limits: Water (moisture) content above the approved product specifications. Status: Terminated.

Entities

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 2023-07-19; 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: Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By:…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-teva-pharmaceuticals-usa-inc-d-0913-2023
MLA
"Teva Pharmaceuticals USA Inc — Class II recall: Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By:…." Argus HQ Research, Digital Empire Holdings LLC, 2023, argushq.ai/events/fda-recall-teva-pharmaceuticals-usa-inc-d-0913-2023.
Chicago
Argus HQ Research. "Teva Pharmaceuticals USA Inc — Class II recall: Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By:…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-teva-pharmaceuticals-usa-inc-d-0913-2023.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_teva_pharmaceuticals_usa_inc_d_0913_2023_2023,
  title = {Teva Pharmaceuticals USA Inc — Class II recall: Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By:…},
  author = {{Argus HQ Research}},
  year = {2023},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-teva-pharmaceuticals-usa-inc-d-0913-2023},
  note = {Accessed: July 23, 2026}
}

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

Teva Pharmaceuticals USA Inc — Class II recall: Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By:… · Argus HQ