Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96003

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

Open FDA event record

Event summary

Timeline bucket
December 18, 2024
Product types
Drug
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Alcon Research LLC

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

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

Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth Worth, TX 76134

D-0200-2025
Recall number
D-0200-2025
Initiated
December 18, 2024
Classification
Class I
Status
Ongoing
Recalling firm
Alcon Research LLC
Quantity
55,960 25-count boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Non-Sterility

Code information

Lot 10101; Exp.09/30/2025

Distribution pattern

US Nationwide.