Recall events
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Event 94703
Event summary
Timeline bucket May 28, 2024
Product types Drug
Classifications Class III
Statuses Ongoing
Recalling firm wording Organon 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
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
3 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 3
Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 60 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subsidiary of Organon & Co. Product of Singapore. NDC 78206-114-02
D-0550-2024
Recall number D-0550-2024
Initiated May 28, 2024
Classification Class III
Status Ongoing
Quantity 2,886 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Defective Container
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Defective Container
Code information Lot #: X025346, Exp 3/3/2025
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[17684]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 3
Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 14 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subsidiary of Organon & Co. Product of Singapore. NDC 78206-114-03
D-0551-2024
Recall number D-0551-2024
Initiated May 28, 2024
Classification Class III
Status Ongoing
Quantity 2,551 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Defective Container
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Defective Container
Code information Lot #: X024051, Exp 04/25/2025
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[17755]
FDA event record
· Exact recall-number query on openFDA
drug · product 3 of 3
Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 30 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subsidiary of Organon & Co. Product of Singapore. NDC 78206-0114-04
D-0552-2024
Recall number D-0552-2024
Initiated May 28, 2024
Classification Class III
Status Ongoing
Quantity 0
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Defective Container
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Defective Container
Code information Lot #: Y000085, Exp 4/25/2025
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[924]
FDA event record
· Exact recall-number query on openFDA
