Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported June 20, 2012
Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, labeled as a) Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 54092-554-30; b) Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 68968-5554-3.
Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remov…
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Noven Pharmaceuticals, Inc. recalled Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2 mg/… - a moderate-severity action.
Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2 mg/… was recalled by Noven Pharmaceuticals, Inc. in June 20, 2012. Reason: Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or…. Check the official notice for the remedy. Verify recall #D-1372-2012 with the FDA Drug before acting.
The recall
Noven Pharmaceuticals, Inc. issued this moderate-severity FDA Drug recall-Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or….
- Moderate
- severity level
- Class II
- classification
- June 20, 2012
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-1372-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-1372-2012) was formally reported on June 20, 2012, with the manufacturer initiating the action on July 5, 2011. It is classified under Moderate severity (Class II), with a current status of Terminated. Noven Pharmaceuticals, Inc. is listed as the recalling firm, operating out of Miami, FL. Federal records list the affected scope as 357,510 patches.
The documented reason for this recall is: Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhes… Distribution data in the federal record shows the product reached: Nationwide and Puerto Rico.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
357,510 patches
Related Recalls
6
5 from same agency
Product description
Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, labeled as a) Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 54092-554-30; b) Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 68968-5554-3.
Reason for recall
Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-1372-2012 |
| Date reported | June 20, 2012 |
| Date initiated | July 5, 2011 |
| Recalling firm | Noven Pharmaceuticals, Inc. |
| Firm location | Miami, FL |
| Affected scope | 357,510 patches |
| Distribution | Nationwide and Puerto Rico. |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-1372-2012) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, labeled as a) Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 54092-554-30; b) Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 68968-5554-3.. Recalled by Noven Pharmaceuticals, Inc.. Units affected: 357,510 patches.
Why was this product recalled? ▼
Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 20, 2012. Severity: Moderate. Recall number: D-1372-2012.
Where was the recalled product distributed? ▼
Distribution: Nationwide and Puerto Rico..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-1372-2012) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported June 20, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.