Ajanta Pharma USA Inc's Complete FDA Record

FDA action counts

Enforcement history

On 2026-06-24, Argus HQ recorded a FDA recall for Ajanta Pharma USA Inc, rated "high" severity in Argus HQ's classification: Ajanta Pharma USA Inc — Class II recall: Aripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Ajanta Pharma… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-07-01, Argus HQ recorded a FDA recall for Ajanta Pharma USA Inc, rated "high" severity in Argus HQ's classification: Ajanta Pharma USA Inc — Class II recall: Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta… 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 USA Inc has 2 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. 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.

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Ajanta Pharma USA Inc has 2 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.

Frequently asked questions

How many FDA actions has Ajanta Pharma USA Inc had?

Argus HQ has recorded 2 FDA events for Ajanta Pharma USA Inc: 0 warning letters, 2 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.

What is the most recent FDA action against Ajanta Pharma USA Inc?

The most recent FDA event Argus HQ has on file for Ajanta Pharma USA Inc is dated 2026-07-01, with a severity rating of "high" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Does Argus HQ track new FDA actions for Ajanta Pharma USA Inc automatically?

Yes. Argus HQ ingests FDA sources daily, including FDA warning letters, recalls, drug and biologic approvals, and Form 483 inspection observations. When a new FDA action linked to Ajanta Pharma USA Inc is observed, this page's event count and history update automatically.

How many FDA actions does Argus HQ track for Ajanta Pharma USA Inc?

2 total: 0 warning letters, 2 recalls, 0 approval records, and 0 Form 483 inspection citations.

Related enforcement actions

• Ajanta Pharma USA Inc — Class II recall: Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta… →
• Ajanta Pharma USA Inc — Class II recall: Aripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Ajanta Pharma… →

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