Class III · Low risk Ongoing
Focalin XR
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Daytrana
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Defective Delivery System: Customer complaints received for ripping patches and tight release/adhesive transfer.
What was recalled
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC 68968-5552-3
- Recalling firm
- Noven Pharmaceuticals Inc
- NDC code
- 68968-5552-3
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1169-2022
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Methylphenidate recalls
See all
Class II · Moderate risk Terminated
Methylphenidate Hydrochloride
Reason Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
Class II · Moderate risk Terminated
Methylphenidate Hydrochloride Tablets
Reason Presence of Foreign Substance: Metal embedded in a tablet.
Class II · Moderate risk Ongoing
Daytrana
Reason Defective Delivery System: Out of specification for shear.
Class II · Moderate risk Ongoing
Daytrana
Reason Defective Delivery System: Out of specification for shear.
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