Medications & Supplements/Prescription Drugs

Noven Pharmaceuticals Inc: Daytrana ADHD Patches Recalled for Defective Delivery and Ripping

Agency Publication Date: May 24, 2021

Summary

Noven Pharmaceuticals Inc. is recalling 16,276 boxes of Daytrana (methylphenidate transdermal system) patches because the delivery system is defective. Specifically, the company received an excessive number of customer complaints regarding patches that rip during use, have difficulty releasing from the packaging, or transfer adhesive improperly. This recall involves the 10 mg and 15 mg dosage strengths, sold in boxes of 30 patches each. Consumers should contact their healthcare provider or pharmacist regarding this defect as it may impact the delivery of the medication.

Risk

The defective delivery system can cause the patches to rip or fail to release correctly from the protective liner. This may result in the patient receiving an incorrect dose of the medication or being unable to use the patch as prescribed for the treatment of ADHD.

What You Should Do

Check your Daytrana (methylphenidate transdermal system) packaging to see if you have the affected dosage strengths: 10 mg over 9 hours (1.1 mg/hr) or 15 mg over 9 hours (1.6 mg/hr).
Look for Lot number 88528 with an expiration date of 09/2021 on the 10 mg patches (NDC 68968-5552-3).
Look for Lot number 88530 with an expiration date of 10/2021 on the 15 mg patches (NDC 68968-5553-3).
If you have an affected patch, contact your healthcare provider or pharmacist for guidance on continuing your treatment and to report any issues with the patch delivery.
Return any unused, affected product to your pharmacy for a refund and to ensure the defective units are properly handled.
Contact Noven Pharmaceuticals Inc. at their Miami, Florida location for further instructions or questions regarding this recall.
For additional questions or to report a side effect, 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

Pharmaceutical product return and refund.

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 (1.1 mg/hr), 30 Patches per box

Model:

NDC 68968-5552-1 (Patch)

NDC 68968-5552-3 (Box)

D-0393-2021

Lot Numbers:

88528 (Exp. 09/2021)

Date Ranges: Expiration 09/2021

Product: Daytrana (methylphenidate transdermal system), 15 mg over 9 hours (1.6 mg/hr), 30 Patches per box

Model:

NDC 68968-5553-1 (Patch)

NDC 68968-5553-3 (Box)

D-0394-2021

Lot Numbers:

88530 (Exp. 10/2021)

Date Ranges: Expiration 10/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87980

Status: Active

Manufacturer: Noven Pharmaceuticals Inc

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 2 products (9,587 boxes; 6,689 boxes)

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 (methylphenidate transdermal system) packaging to see if you have the affected dosage strengths: 10 mg over 9 hours (1.1 mg/hr) or 15 mg over 9 hours (1.6 mg/hr).

Look for Lot number 88528 with an expiration date of 09/2021 on the 10 mg patches (NDC 68968-5552-3).

Look for Lot number 88530 with an expiration date of 10/2021 on the 15 mg patches (NDC 68968-5553-3).

If you have an affected patch, contact your healthcare provider or pharmacist for guidance on continuing your treatment and to report any issues with the patch delivery.

Return any unused, affected product to your pharmacy for a refund and to ensure the defective units are properly handled.

Contact Noven Pharmaceuticals Inc. at their Miami, Florida location for further instructions or questions regarding this recall.

For additional questions or to report a side effect, 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 (1.1 mg/hr), 30 Patches per box

Model:

NDC 68968-5552-1 (Patch)

NDC 68968-5552-3 (Box)

D-0393-2021

Lot Numbers:

88528 (Exp. 09/2021)

Date Ranges: Expiration 09/2021

Product: Daytrana (methylphenidate transdermal system), 15 mg over 9 hours (1.6 mg/hr), 30 Patches per box

Model:

NDC 68968-5553-1 (Patch)

NDC 68968-5553-3 (Box)

D-0394-2021

Lot Numbers:

88530 (Exp. 10/2021)

Date Ranges: Expiration 10/2021