Recall events
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Event 93346
Event summary
Timeline bucket October 31, 2023
Product types Drug
Classifications Class I
Statuses Ongoing
Recalling firm wording Cardinal Health 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
6 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 6
LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017, Made in India NDC: 70000-0087-1
D-0131-2024
Recall number D-0131-2024
Initiated October 31, 2023
Classification Class I
Status Ongoing
Quantity 11629 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[15020]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 6
LEADER brand Dry Eye Relief (Carboxymethylcellulose Sodium, 1%); 0.5 FL OZ (15 mL) dropper bottle, Sterile, Distributed By Cardinal Health, Dublin, Ohio. 43017, Made in India NDC: 70000-0089-1
D-0132-2024
Recall number D-0132-2024
Initiated October 31, 2023
Classification Class I
Status Ongoing
Quantity 21,802 bottles
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[14915]
FDA event record
· Exact recall-number query on openFDA
drug · product 3 of 6
LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017. Made in India NDC: 70000-0090-1
D-0133-2024
Recall number D-0133-2024
Initiated October 31, 2023
Classification Class I
Status Ongoing
Quantity 119,871 bottles
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[16340]
FDA event record
· Exact recall-number query on openFDA
drug · product 4 of 6
LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 2 bottles, 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017, Made in India NDC:70000-0090-2 (Carton); 70000-0090-1 (Bottle)
D-0134-2024
Recall number D-0134-2024
Initiated October 31, 2023
Classification Class I
Status Ongoing
Quantity 28477 cartons
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[15637]
FDA event record
· Exact recall-number query on openFDA
drug · product 5 of 6
LEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0.4% Propylene Glycol, 0.3%); 0.33 FL OZ (10 mL) dropper bottle, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017, Made in India NDC: 70000-0088-1
D-0135-2024
Recall number D-0135-2024
Initiated October 31, 2023
Classification Class I
Status Ongoing
Quantity 11,782 bottles
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[15636]
FDA event record
· Exact recall-number query on openFDA
drug · product 6 of 6
LEADER brand Lubricant Eye Drops (Propylene Glycol, 0.6%); 0.33 FL OZ (10 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017. Made in India NDC: 70000-0587-1
D-0136-2024
Recall number D-0136-2024
Initiated October 31, 2023
Classification Class I
Status Ongoing
Quantity 8,784 bottles
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13193]
FDA event record
· Exact recall-number query on openFDA
