Recall events
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Event 78021
Event summary
Timeline bucket August 30, 2017
Product types Drug
Classifications Class II
Statuses Terminated
Recalling firm wording Noven Pharmaceuticals, 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
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) Delivers 10 mg over 9 hours (1.1 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC# 68968-5552-3
D-1169-2017
Recall number D-1169-2017
Initiated August 30, 2017
Classification Class II
Status Terminated
Quantity 321,900 patches
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Code information Lot: 80433 Exp. 08/17
Distribution pattern 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[15971]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 4
Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC# 68968-5554-3
D-1170-2017
Recall number D-1170-2017
Initiated August 30, 2017
Classification Class II
Status Terminated
Quantity 182,850 patches
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Code information Lot: 80431 Exp. 08/17
Distribution pattern 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[15914]
FDA event record
· Exact recall-number query on openFDA
drug · product 3 of 4
Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC# 68968-5555-3
D-1171-2017
Recall number D-1171-2017
Initiated August 30, 2017
Classification Class II
Status Terminated
Quantity 331,950 patches
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Code information Lot: 80442 Exp. 10/17 Lot: 80439 Exp. 08/17 Lot: 80438 Exp. 08/17
Distribution pattern 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[16005]
FDA event record
· Exact recall-number query on openFDA
drug · product 4 of 4
Daytrana (methylphenidate transdermal system) Delivers 15 mg over 9 hours (1.6 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC# 68968-5553-3
D-1172-2017
Recall number D-1172-2017
Initiated August 30, 2017
Classification Class II
Status Terminated
Quantity 234,960 patches
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Code information Lot: 80426 Exp. 10/17
Distribution pattern 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[15913]
FDA event record
· Exact recall-number query on openFDA
