Daytrana (methylphenidate transdermal system) CII, 10mg, 30-count carton, Rx only…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Recalling firm

Noven Pharmaceuticals Inc

NDC code

68968-5552-3

Origin

FL, United States

Initiated by

Voluntary: Firm initiated

FDA recall number

D-0470-2023

Other Methylphenidate recalls

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Class III · Low risk Ongoing Jun 1, 2026

Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDMO…

Reason Labeling: Incorrect or Missing Lot and/or Exp Date

Sandoz Inc D-0608-2026

Class II · Moderate risk Terminated Jun 17, 2024

Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen…

Reason Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.

Trigen Laboratories NDC 13811-708-10 D-0579-2024

Class II · Moderate risk Terminated Jul 13, 2023

Methylphenidate Hydrochloride Tablets, USP 20mg, Rx Only, 100 Tablets per bottle, Manufactured by: Ohm Laboratories Inc., New…

Reason Presence of Foreign Substance: Metal embedded in a tablet.

Sun Pharmaceutical Industries INC NDC 57664-230-88 D-0940-2023

Class II · Moderate risk Ongoing Mar 10, 2023

Daytrana (methylphenidate transdermal system) CII, 30 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC…

Reason Defective Delivery System: Out of specification for shear.

Noven Pharmaceuticals Inc NDC 68968-5555-3 D-0473-2023

Class II · Moderate risk Ongoing Mar 10, 2023

Daytrana (methylphenidate transdermal system) CII, 20mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC…

Reason Defective Delivery System: Out of specification for shear.

Noven Pharmaceuticals Inc NDC 68968-5554-3 D-0472-2023