Recall events
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Event 85128
Event summary
Timeline bucket March 02, 2020
Product types Drug
Classifications Class II
Statuses Terminated
Recalling firm wording Noven Therapeutics, 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
4 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 4
Daytrana (methylphenidate transdermal system) patches, Delivers 10 mg over 9 hours (1.1 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC. Miami, FL 33186, NDC 68968-5552-3
D-1042-2020
Recall number D-1042-2020
Initiated March 02, 2020
Classification Class II
Status Terminated
Quantity 9513 boxes
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Out of specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Defective Delivery System: Out of specification for mechanical peel and shear.
Code information Lot#: 86280, Exp 06/2020
Distribution pattern U.S.A. 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[16318]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 4
Daytrana (methylphenidate transdermal system) patches, Delivers 15 mg over 9 hours (1.6 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC. Miami, FL 33186, NDC 68968-5553-3
D-1043-2020
Recall number D-1043-2020
Initiated March 02, 2020
Classification Class II
Status Terminated
Quantity 13761 boxes
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Out of specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Defective Delivery System: Out of specification for mechanical peel and shear.
Code information Lot#: 85942, Exp 03/2020; 86281, Exp 06/2020
Distribution pattern U.S.A. 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[16322]
FDA event record
· Exact recall-number query on openFDA
drug · product 3 of 4
Daytrana (methylphenidate transdermal system) patches, Delivers 20 mg over 9 hours (2.2 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC. Miami, FL 33186, NDC 68968-5554-3
D-1044-2020
Recall number D-1044-2020
Initiated March 02, 2020
Classification Class II
Status Terminated
Quantity 11093 boxes
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Out of specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Defective Delivery System: Out of specification for mechanical peel and shear.
Code information Lo#t: 86081, Exp 04/2020; 86196, Exp 06/2020
Distribution pattern U.S.A. 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[15959]
FDA event record
· Exact recall-number query on openFDA
drug · product 4 of 4
Daytrana (methylphenidate transdermal system) patches, Delivers 30 mg over 9 hours (3.3 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC. Miami, FL 33186, NDC 68968-5555-3
D-1045-2020
Recall number D-1045-2020
Initiated March 02, 2020
Classification Class II
Status Terminated
Quantity 7469 boxes
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Out of specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Defective Delivery System: Out of specification for mechanical peel and shear.
Code information Lot#: 86083, Exp 05/2020; 86282, Exp 06/2020
Distribution pattern U.S.A. 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[15012]
FDA event record
· Exact recall-number query on openFDA
