Exact FDA event identifier

Event 99130

1 recalled-product record grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: May 28, 2026
Product types: Drug
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Ajanta Pharma USA Inc

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma Limited, India, Marketed by: Ajanta Pharma USA Inc. Bridgewater, NJ 08807, NDC 27241-120-04.

D-0611-2026

Recall number: D-0611-2026
Initiated: May 28, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Ajanta Pharma USA Inc
Quantity: 3648 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations

Code information

Lot # PA02216; Exp. 12/2029

Distribution pattern

U.S. Nationwide