Medications & Supplements/Prescription Drugs

Daytrana (methylphenidate) Patches Recalled for Defective Delivery System

Agency Publication Date: March 20, 2023

Summary

Noven Pharmaceuticals Inc. has recalled several lots of Daytrana (methylphenidate transdermal system) CII patches, a prescription medication used to treat ADHD. The recall was initiated because the patches may have a defective delivery system that failed adhesive shear testing. This defect affects the 10mg, 15mg, 20mg, and 30mg dosage strengths sold in 30-count cartons.

Risk

The defective adhesive system means the patches may not adhere properly to the skin or may be difficult to remove from the liner, potentially leading to improper medication delivery or skin irritation.

What You Should Do

The recalled products are Daytrana (methylphenidate transdermal system) CII patches in 10mg, 15mg, 20mg, and 30mg strengths sold in 30-count cartons.
Check your medication packaging for NDC codes 68968-5552-3, 68968-5553-3, 68968-5554-3, or 68968-5555-3. You should also verify the lot numbers and expiration dates on the carton, which include lots such as 91955, 91956, 91957, and 91474. See the Affected Products section below for the full list of affected codes.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Daytrana (methylphenidate transdermal system) CII (10mg)

Variants: 10mg, 30-count carton

Lot Numbers:

91955 (Exp. 7/2023)

93039 (Exp. 10/2023)

NDC:

68968-5552-3

Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc.

Product: Daytrana (methylphenidate transdermal system) CII (15mg)

Variants: 15mg, 30-count carton

Lot Numbers:

91956 (Exp. 6/2023)

92475 (Exp. 7/2023)

NDC:

68968-5553-3

Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc.

Product: Daytrana (methylphenidate transdermal system) CII (20mg)

Variants: 20mg, 30-count carton

Lot Numbers:

91957 (Exp. 7/2023)

92197 (Exp. 7/2023)

92476 (Exp. 9/2023)

92477 (Exp. 10/2023)

NDC:

68968-5554-3

Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc.

Product: Daytrana (methylphenidate transdermal system) CII (30mg)

Variants: 30mg, 30-count carton

Lot Numbers:

91474 (Exp. 3/2023)

91959 (Exp. 3/2023)

91958 (Exp. 6/2023)

92478 (Exp. 7/2023)

92479 (Exp. 8/2023)

92198 (Exp. 8/2023)

92199 (Exp. 9/2023)

93040 (Exp. 9/2023)

93041 (Exp. 10/2023)

NDC:

68968-5555-3

Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91882

Status: Active

Manufacturer: Noven Pharmaceuticals Inc

Sold By: Retail Pharmacies

Manufactured In: United States

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

The recalled products are Daytrana (methylphenidate transdermal system) CII patches in 10mg, 15mg, 20mg, and 30mg strengths sold in 30-count cartons.

Check your medication packaging for NDC codes 68968-5552-3, 68968-5553-3, 68968-5554-3, or 68968-5555-3. You should also verify the lot numbers and expiration dates on the carton, which include lots such as 91955, 91956, 91957, and 91474. See the Affected Products section below for the full list of affected codes.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Daytrana (methylphenidate transdermal system) CII (10mg)

Variants: 10mg, 30-count carton

Lot Numbers:

91955 (Exp. 7/2023)

93039 (Exp. 10/2023)

NDC:

68968-5552-3

Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc.

Product: Daytrana (methylphenidate transdermal system) CII (15mg)

Variants: 15mg, 30-count carton

Lot Numbers:

91956 (Exp. 6/2023)

92475 (Exp. 7/2023)

NDC:

68968-5553-3

Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc.

Product: Daytrana (methylphenidate transdermal system) CII (20mg)

Variants: 20mg, 30-count carton

Lot Numbers:

91957 (Exp. 7/2023)

92197 (Exp. 7/2023)

92476 (Exp. 9/2023)

92477 (Exp. 10/2023)

NDC:

68968-5554-3

Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc.

Product: Daytrana (methylphenidate transdermal system) CII (30mg)

Variants: 30mg, 30-count carton

Lot Numbers:

91474 (Exp. 3/2023)

91959 (Exp. 3/2023)

91958 (Exp. 6/2023)

92478 (Exp. 7/2023)

92479 (Exp. 8/2023)

92198 (Exp. 8/2023)

92199 (Exp. 9/2023)

93040 (Exp. 9/2023)

93041 (Exp. 10/2023)

NDC:

68968-5555-3

Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc.