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fda_recall · drug_recall · medium

Ajanta Pharma USA Inc — Class III recall: Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Marke…

Event date
2026-09-16 00:00:00Z
Observed
2026-09-23 04:20:19Z
Source ID
D-0836-2026
Payload hash
2c7339a5a496aa92e5d61cbd…

Summary

Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0 percent. Status: Ongoing.

Entities

View source record ↗

Frequently asked questions

Has Ajanta Pharma USA Inc had other FDA enforcement actions?
Yes. Argus HQ has recorded 4 total FDA actions tied to Ajanta Pharma USA Inc: 0 warning letters, 4 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 medium severity by Argus HQ. FDA published the underlying record on 2026-09-16; Argus observed and indexed it on 2026-09-23.
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). Ajanta Pharma USA Inc — Class III recall: Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only,  Marke…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-ajanta-pharma-usa-inc-d-0836-2026
MLA
"Ajanta Pharma USA Inc — Class III recall: Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only,  Marke…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-ajanta-pharma-usa-inc-d-0836-2026.
Chicago
Argus HQ Research. "Ajanta Pharma USA Inc — Class III recall: Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only,  Marke…." Digital Empire Holdings LLC. Accessed October 13, 2026. https://argushq.ai/events/fda-recall-ajanta-pharma-usa-inc-d-0836-2026.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_ajanta_pharma_usa_inc_d_0836_2026_2026,
  title = {Ajanta Pharma USA Inc — Class III recall: Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only,  Marke…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-ajanta-pharma-usa-inc-d-0836-2026},
  note = {Accessed: October 13, 2026}
}

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

Ajanta Pharma USA Inc — Class III recall: Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Marke… · Argus HQ