Medications & Supplements/Prescription Drugs

Noven Pharmaceuticals Inc: Daytrana (methylphenidate) Patches Recalled Due to Defective Delivery System

Agency Publication Date: March 3, 2021

Summary

Noven Pharmaceuticals is recalling approximately 2.7 million Daytrana (methylphenidate transdermal system) patches across multiple dosage strengths. The recall was initiated because the patches are "out of specification for mechanical peel," meaning the delivery system is defective and users may have difficulty peeling the backing off the patch to apply it. These prescription patches are used to treat ADHD and were distributed nationwide in the USA in paper cartons containing foil-sealed trays of 30 patches.

Risk

A defect in the mechanical peel process can make it difficult or impossible to remove the protective liner from the medicated patch. This delivery system failure may lead to delays in treatment or improper application of the medication.

What You Should Do

Check your Daytrana packaging for the following dosage strengths and National Drug Codes (NDC): 10 mg (NDC 68968-5552-3), 15 mg (NDC 68968-5553-3), 20 mg (NDC 68968-5554-3), or 30 mg (NDC 68968-5555-3).
Verify if your specific lot number and expiration date are included: for 10 mg, look for Lots 87579 (Exp 3/2021) or 88243 (Exp 7/2021); for 15 mg, look for Lots 87818 (Exp 4/2021), 88274 (Exp 5/2021), or 88531 (Exp 7/2021).
For 20 mg patches, check for Lots 87580 (Exp 4/2021), 87819 (Exp 4/2021), 88244 (Exp 6/2021), 88245 (Exp 6/2021), 88532 (Exp 06/2021), or 88533 (Exp 7/2021).
For 30 mg patches, check for Lots 87377 (Exp 3/2021), 87572 (Exp 3/2021), 87581 (Exp 4/2021), 87820 (Exp 5/2021), 88246 (Exp 6/2021), 88535 (Exp 7/2021), 88536 (Exp 8/2021), 88537 (Exp 8/2021), or 88939 (Exp 8/2021).
If you have an affected product, contact your healthcare provider or pharmacist for guidance regarding your treatment and to obtain a replacement prescription if necessary.
Return any unused, recalled patches to your pharmacy for a refund and contact Noven Pharmaceuticals at their Miami office for further instructions.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Return product to pharmacy

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Daytrana (methylphenidate transdermal system), 10 mg over 9 hours

Model:

NDC 68968-5552-3

Recall #: D-0293-2021

Lot Numbers:

87579 (Exp 3/2021)

88243 (Exp 7/2021)

Date Ranges: Expiration March 2021, Expiration July 2021

Product: Daytrana (methylphenidate transdermal system), 15 mg over 9 hours

Model:

NDC 68968-5553-3

Recall #: D-0294-2021

Lot Numbers:

87818 (Exp 4/2021)

88274 (Exp 5/2021)

88531 (Exp 7/2021)

Date Ranges: Expiration April 2021, Expiration May 2021, Expiration July 2021

Product: Daytrana (methylphenidate transdermal system), 20 mg over 9 hours

Model:

NDC 68968-5554-3

Recall #: D-0295-2021

Lot Numbers:

87580 (Exp 4/2021)

87819 (Exp 4/2021)

88244 (Exp 6/2021)

88245 (Exp 6/2021)

88532 (Exp 06/2021)

88533 (Exp 7/2021)

Date Ranges: Expiration April 2021, Expiration June 2021, Expiration July 2021

Product: Daytrana (methylphenidate transdermal system), 30 mg over 9 hours

Model:

NDC 68968-5555-3

Recall #: D-0296-2021

Lot Numbers:

87377 (Exp 3/2021)

87572 (Exp 3/2021)

87581 (Exp 4/2021)

87820 (Exp 5/2021)

88246 (Exp 6/2021)

88535 (Exp 7/2021)

88536 (Exp 8/2021)

88537 (Exp 8/2021)

88939 (Exp 8/2021)

Date Ranges: Expiration March 2021, Expiration April 2021, Expiration May 2021, Expiration June 2021, Expiration July 2021, Expiration August 2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87373

Status: Resolved

Manufacturer: Noven Pharmaceuticals Inc

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 4 products (473,280 patches; 551,670 patches; 786,900 patches; 934,140 patches)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your Daytrana packaging for the following dosage strengths and National Drug Codes (NDC): 10 mg (NDC 68968-5552-3), 15 mg (NDC 68968-5553-3), 20 mg (NDC 68968-5554-3), or 30 mg (NDC 68968-5555-3).

Verify if your specific lot number and expiration date are included: for 10 mg, look for Lots 87579 (Exp 3/2021) or 88243 (Exp 7/2021); for 15 mg, look for Lots 87818 (Exp 4/2021), 88274 (Exp 5/2021), or 88531 (Exp 7/2021).

For 20 mg patches, check for Lots 87580 (Exp 4/2021), 87819 (Exp 4/2021), 88244 (Exp 6/2021), 88245 (Exp 6/2021), 88532 (Exp 06/2021), or 88533 (Exp 7/2021).

For 30 mg patches, check for Lots 87377 (Exp 3/2021), 87572 (Exp 3/2021), 87581 (Exp 4/2021), 87820 (Exp 5/2021), 88246 (Exp 6/2021), 88535 (Exp 7/2021), 88536 (Exp 8/2021), 88537 (Exp 8/2021), or 88939 (Exp 8/2021).

If you have an affected product, contact your healthcare provider or pharmacist for guidance regarding your treatment and to obtain a replacement prescription if necessary.

Return any unused, recalled patches to your pharmacy for a refund and contact Noven Pharmaceuticals at their Miami office for further instructions.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Daytrana (methylphenidate transdermal system), 10 mg over 9 hours

Model:

NDC 68968-5552-3

Recall #: D-0293-2021

Lot Numbers:

87579 (Exp 3/2021)

88243 (Exp 7/2021)

Date Ranges: Expiration March 2021, Expiration July 2021

Product: Daytrana (methylphenidate transdermal system), 15 mg over 9 hours

Model:

NDC 68968-5553-3

Recall #: D-0294-2021

Lot Numbers:

87818 (Exp 4/2021)

88274 (Exp 5/2021)

88531 (Exp 7/2021)

Date Ranges: Expiration April 2021, Expiration May 2021, Expiration July 2021

Product: Daytrana (methylphenidate transdermal system), 20 mg over 9 hours

Model:

NDC 68968-5554-3

Recall #: D-0295-2021

Lot Numbers:

87580 (Exp 4/2021)

87819 (Exp 4/2021)

88244 (Exp 6/2021)

88245 (Exp 6/2021)

88532 (Exp 06/2021)

88533 (Exp 7/2021)

Date Ranges: Expiration April 2021, Expiration June 2021, Expiration July 2021

Product: Daytrana (methylphenidate transdermal system), 30 mg over 9 hours

Model:

NDC 68968-5555-3

Recall #: D-0296-2021

Lot Numbers:

87377 (Exp 3/2021)

87572 (Exp 3/2021)

87581 (Exp 4/2021)

87820 (Exp 5/2021)

88246 (Exp 6/2021)

88535 (Exp 7/2021)

88536 (Exp 8/2021)

88537 (Exp 8/2021)

88939 (Exp 8/2021)

Date Ranges: Expiration March 2021, Expiration April 2021, Expiration May 2021, Expiration June 2021, Expiration July 2021, Expiration August 2021