Has Ajanta Pharma Ltd. had other FDA enforcement actions?

Yes. Argus HQ has recorded 4 total FDA actions tied to Ajanta Pharma Ltd.: 0 warning letters, 3 recalls, 1 approval record, 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 2026-05-13; 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

Ajanta Pharma Ltd. — Class II recall: Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-0…

Name: FDA Recall Record — Ajanta Pharma Ltd.
Creator: Argus HQ
Published: 2026-05-13
License: https://argushq.ai/methodology

Event date: 2026-05-13 00:00:00Z
Observed: 2026-07-09 22:51:41Z
Source ID: D-0514-2026
Payload hash: 91d2ff334403e7659369b5f1…

Summary

CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals. Status: Ongoing.

Entities

Ajanta Pharma Ltd.

View source record ↗

Frequently asked questions

Has Ajanta Pharma Ltd. had other FDA enforcement actions?: Yes. Argus HQ has recorded 4 total FDA actions tied to Ajanta Pharma Ltd.: 0 warning letters, 3 recalls, 1 approval record, 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 2026-05-13; 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). Ajanta Pharma Ltd. — Class II recall: Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-0…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-ajanta-pharma-ltd-d-0514-2026

MLA

"Ajanta Pharma Ltd. — Class II recall: Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-0…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-ajanta-pharma-ltd-d-0514-2026.

Chicago

Argus HQ Research. "Ajanta Pharma Ltd. — Class II recall: Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-0…." Digital Empire Holdings LLC. Accessed September 23, 2026. https://argushq.ai/events/fda-recall-ajanta-pharma-ltd-d-0514-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_ajanta_pharma_ltd_d_0514_2026_2026,
  title = {Ajanta Pharma Ltd. — Class II recall: Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-0…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-ajanta-pharma-ltd-d-0514-2026},
  note = {Accessed: September 23, 2026}
}

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