Recall events
/
Event 97888
Event summary
Timeline bucket October 29, 2025
Product types Drug
Classifications Class I
Statuses Ongoing
Recalling firm wording Otsuka ICU Medical 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
2 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 2
POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly concentrated 400 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7077-14
D-0180-2026
Recall number D-0180-2026
Initiated October 29, 2025
Classification Class I
Status Ongoing
Quantity 21,696 50mL flexible containers
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Label Error
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq
Code information Lot # 1030613, Exp Date: 09/30/2026
Distribution pattern US Nationwide.
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[17457]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 2
POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly concentrated 100 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26
D-0181-2026
Recall number D-0181-2026
Initiated October 29, 2025
Classification Class I
Status Ongoing
Quantity Unavailable
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Label Error
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq
Code information Lot # 1030613, Exp Date: 09/30/2026
Distribution pattern US Nationwide.
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[17727]
FDA event record
· Exact recall-number query on openFDA
