Exact FDA event identifier

Event 99019

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

Open FDA event record

Event summary

Timeline bucket: May 14, 2026
Product types: Drug
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Asclemed 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

Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-634-30, Marketed by: Ajanta Pharma USA Inc.

D-0555-2026

Recall number: D-0555-2026
Initiated: May 14, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Asclemed USA Inc.
Quantity: 50 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

Nitrosamine Drug Substance Related Impurity

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; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.

Code information

Lot # 050725G-30 & 050725F-30, Exp Date: 06/30/2026

Distribution pattern

US Nationwide.