Recall events
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Event 97808
Event summary
Timeline bucket October 15, 2025
Product types Drug
Classifications Class II
Statuses Ongoing
Recalling firm wording ProRx 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
7 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 7
Semaglutide Injection, 12.5/5mL (2.5 mg/mL), 5mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-09
D-0114-2026
Recall number D-0114-2026
Initiated October 15, 2025
Classification Class II
Status Ongoing
Quantity 2,809 vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of Assurance of Sterility
Code information Lot# Prorx04282025-3
Distribution pattern TX and UT
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[15242]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 7
Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-04
D-0115-2026
Recall number D-0115-2026
Initiated October 15, 2025
Classification Class II
Status Ongoing
Quantity 8,400 vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of Assurance of Sterility
Code information Lot, Best Use Date (BUD): Lot PRORX050925-1, BUD November 4, 2025; Lot ProRx051425-5, BUD November 10, 2025; Lot ProRx051425-6, BUD November 10, 2025
Distribution pattern TX and UT
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[16438]
FDA event record
· Exact recall-number query on openFDA
drug · product 3 of 7
Semaglutide Injection, 6mg/2.4mL (2.5 mg/mL), 2.4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-08
D-0116-2026
Recall number D-0116-2026
Initiated October 15, 2025
Classification Class II
Status Ongoing
Quantity 8,310 vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of Assurance of Sterility
Code information Lot Prorx051425-2, Lot Prorx051425-3 and Lot Prorx051425-4
Distribution pattern TX and UT
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[15030]
FDA event record
· Exact recall-number query on openFDA
drug · product 4 of 7
Semaglutide Injection, 8mg/3.2mL (2.5 mg/mL), 3.2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-09
D-0117-2026
Recall number D-0117-2026
Initiated October 15, 2025
Classification Class II
Status Ongoing
Quantity 11,119 vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of Assurance of Sterility
Code information Lot Prorx051525-1, Prorx051525-2, Prorx051525-3 and Prorx051525-4
Distribution pattern TX and UT
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[447]
FDA event record
· Exact recall-number query on openFDA
drug · product 5 of 7
Semaglutide Injection, 2.5mg/1mL (2.5 mg/mL), 1mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-06
D-0118-2026
Recall number D-0118-2026
Initiated October 15, 2025
Classification Class II
Status Ongoing
Quantity 2,649 vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of Assurance of Sterility
Code information Lot Prorx051525-5
Distribution pattern TX and UT
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[431]
FDA event record
· Exact recall-number query on openFDA
drug · product 6 of 7
Semaglutide Injection, 5 mg/2 mL (2.5 mg/mL), 2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-02
D-0119-2026
Recall number D-0119-2026
Initiated October 15, 2025
Classification Class II
Status Ongoing
Quantity 2,805 vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of Assurance of Sterility
Code information Lot PRORX052125-4
Distribution pattern TX and UT
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[15146]
FDA event record
· Exact recall-number query on openFDA
drug · product 7 of 7
Tirzepatide Injection, 27 mg/3 mL (9 mg/mL), 3mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-209-03
D-0120-2026
Recall number D-0120-2026
Initiated October 15, 2025
Classification Class II
Status Ongoing
Quantity 2,761 vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of Assurance of Sterility
Code information Lot PRORX08062025-3
Distribution pattern TX and UT
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[469]
FDA event record
· Exact recall-number query on openFDA
