Has SUN PHARMACEUTICAL INDUSTRIES INC had other FDA enforcement actions?

Yes. Argus HQ has recorded 9 total FDA actions tied to SUN PHARMACEUTICAL INDUSTRIES INC: 0 warning letters, 8 recalls, 0 approval records, and 1 Form 483 inspection citation.

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 2026-06-17; Argus observed and indexed it on 2026-07-09.

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

SUN PHARMACEUTICAL INDUSTRIES INC — Class II recall: Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules…

Name: FDA Recall Record — SUN PHARMACEUTICAL INDUSTRIES INC
Creator: Argus HQ
Published: 2026-06-17
License: https://argushq.ai/methodology

Event date: 2026-06-17 00:00:00Z
Observed: 2026-07-09 22:51:35Z
Source ID: D-0607-2026
Payload hash: af3fccfc24cf108102bb2f12…

Summary

Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution Status: Ongoing.

Entities

SUN PHARMACEUTICAL INDUSTRIES INC

View source record ↗

Frequently asked questions

Has SUN PHARMACEUTICAL INDUSTRIES INC had other FDA enforcement actions?: Yes. Argus HQ has recorded 9 total FDA actions tied to SUN PHARMACEUTICAL INDUSTRIES INC: 0 warning letters, 8 recalls, 0 approval records, and 1 Form 483 inspection citation.
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 2026-06-17; Argus observed and indexed it on 2026-07-09.
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). SUN PHARMACEUTICAL INDUSTRIES INC — Class II recall: Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-sun-pharmaceutical-industries-inc-d-0607-2026

MLA

"SUN PHARMACEUTICAL INDUSTRIES INC — Class II recall: Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-sun-pharmaceutical-industries-inc-d-0607-2026.

Chicago

Argus HQ Research. "SUN PHARMACEUTICAL INDUSTRIES INC — Class II recall: Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules…." Digital Empire Holdings LLC. Accessed August 27, 2026. https://argushq.ai/events/fda-recall-sun-pharmaceutical-industries-inc-d-0607-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_sun_pharmaceutical_industries_inc_d_0607_2026_2026,
  title = {SUN PHARMACEUTICAL INDUSTRIES INC — Class II recall: Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-sun-pharmaceutical-industries-inc-d-0607-2026},
  note = {Accessed: August 27, 2026}
}

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