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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85357

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 31, 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

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

Daytrana (methylphenidate transdermal system) 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-1247-2020
Recall number
D-1247-2020
Initiated
March 31, 2020
Classification
Class II
Status
Terminated
Recalling firm
Noven Therapeutics, LLC
Quantity
7957 30-count 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: 86647 Exp. 09/2020

Distribution pattern

Distributed Nationwide in the US

drug · product 2 of 3

Daytrana (methylphenidate transdermal system) 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-1248-2020
Recall number
D-1248-2020
Initiated
March 31, 2020
Classification
Class II
Status
Terminated
Recalling firm
Noven Therapeutics, LLC
Quantity
5,614 30-count 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: 86354 Exp. 08/2020

Distribution pattern

Distributed Nationwide in the US

drug · product 3 of 3

Daytrana (methylphenidate transdermal system) 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-1249-2020
Recall number
D-1249-2020
Initiated
March 31, 2020
Classification
Class II
Status
Terminated
Recalling firm
Noven Therapeutics, LLC
Quantity
14,142 30-count 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

Lots: 86355 Exp. 07/2020; 86356 Exp.08/2020; 86550 Exp. 07/2020; 87348 Exp. 01/2021; 87965 Exp. 01/2021

Distribution pattern

Distributed Nationwide in the US