What is the most recent FDA action on file for Ajanta Pharma Ltd.?

May 13, 2026. Argus HQ ingests new FDA enforcement records daily.

Has Ajanta Pharma Ltd. had product recalls?

Yes, 3 recalls on file. See the full history below for each one.

Is this FDA enforcement data for Ajanta Pharma Ltd. official?

Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.

Ajanta Pharma Ltd. — FDA Enforcement History

FDA action counts

Total FDA actions	3
Warning letters	0
Recalls	3
Approval records	0
Form 483 inspection citations	0
Most recent action	May 13, 2026

In short: Argus HQ has recorded 3 FDA events for Ajanta Pharma Ltd.: 0 warning letters, 3 recalls, 0 approvals, and 0 inspection 483 observations. These events span from 2026-05-13 to 2026-05-13. The most severe rating Argus HQ has assigned across this history is "high". Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed.

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Ajanta Pharma Ltd. has 3 separate FDA recalls on file, more than a single isolated recall event. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ does not independently verify FDA's underlying findings; this page summarizes what FDA has published and links back to the original FDA source for each event.

Enforcement history

On 2026-05-13, Argus HQ recorded a FDA recall for Ajanta Pharma Ltd., rated "high" severity in Argus HQ's classification: Ajanta Pharma Ltd. — Class II recall: Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-0… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-13, Argus HQ recorded a FDA recall for Ajanta Pharma Ltd., rated "high" severity in Argus HQ's classification: Ajanta Pharma Ltd. — Class II recall: Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: A… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-13, Argus HQ recorded a FDA recall for Ajanta Pharma Ltd., rated "high" severity in Argus HQ's classification: Ajanta Pharma Ltd. — Class II recall: Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: A… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. In total, Ajanta Pharma Ltd. has 3 FDA events on file with Argus HQ across the sources Argus HQ currently tracks (FDA Warning Letters, recalls, drug/biologic approvals, and Form 483 inspection observations). Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed.

Frequently asked questions

What is the most recent FDA action on file for Ajanta Pharma Ltd.?: May 13, 2026. Argus HQ ingests new FDA enforcement records daily.
Has Ajanta Pharma Ltd. had product recalls?: Yes, 3 recalls on file. See the full history below for each one.
Is this FDA enforcement data for Ajanta Pharma Ltd. official?: Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.
How many FDA actions has Ajanta Pharma Ltd. had?: Argus HQ has recorded 3 FDA events for Ajanta Pharma Ltd.: 0 warning letters, 3 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

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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. — FDA Enforcement History. Digital Empire LLC. Retrieved from https://argushq.ai/company/ajanta-pharma-ltd

MLA

"Ajanta Pharma Ltd. — FDA Enforcement History." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/company/ajanta-pharma-ltd.

Chicago

Argus HQ Research. "Ajanta Pharma Ltd. — FDA Enforcement History." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/company/ajanta-pharma-ltd.

BibTeX

@misc{argushq_argushq_ai_company_ajanta_pharma_ltd_2026,
  title = {Ajanta Pharma Ltd. — FDA Enforcement History},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/company/ajanta-pharma-ltd},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗