Lower riskDrug recall · FDA · Published May 6, 2022
Noven Daytrana Recall: Defective Delivery System Risk
Noven Pharmaceuticals recalls Daytrana patches due to defective delivery system causing customer complaints exceeding action limits. This medication is prescription-only and contains 30 patches.
Noven Pharmaceuticals is recalling Daytrana (methylphenidate transdermal system) because customer complaints indicate the delivery system may not be working as intended. This could lead to inconsistent medication levels, but the recall does not mention immediate safety risks like injury or death. Read more at govinfonow.com/recall/34787-noven-daytrana-recall-defective-delivery-system-risk.
“Noven Daytrana Recall: Defective Delivery System Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34787-noven-daytrana-recall-defective-delivery-system-risk. Based on FDA recall #D-0889-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0889-2022%22&limit=1).
The Food and Drug Administration announced on May 6, 2022, that Noven Pharmaceuticals Inc is recalling Daytrana (methylphenidate transdermal system) due to a defective delivery system. The agency stated that customer complaints regarding the patches exceeded respective action limits.
The recall addresses a defective delivery system where customer complaints exceeded respective action limits. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Noven Pharmaceuticals Inc has 24 other recalls on record since July 5, 2011. Other recent recalls of similar products include Noven Xelstrym 13.5mg Transdermal System Recall (Oct. 31, 2024), Noven Daytrana 20mg Transdermal System Recall (March 10, 2023), and Noven Daytrana patches recalled due to defective adhesive delivery (Nov. 16, 2022). Other recent recalls of similar products include Xyvona (Levorphanol) 2mg Tablet Recall (May 22, 2026), Bionpharma Divalproex Tablets Recall (June 26, 2026), and SUN PHARMACEUTICAL Xyvona 3mg Tablets Recall (May 22, 2026).
How to tell if you have this one
Check for Daytrana patches with NDC 68968-5552-3, manufactured in Miami, FL, with expiration date 08/2022. This product is prescription-only and contains 30 patches.
Brand
Noven
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the NDC number 68968-5552-3 and expiration date 08/2022 on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide to the U.S. Market” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 26 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0889-2022 (May 6, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0889-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.