Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Is Methylphenidate recalled?

Yes — there is an active recall. 10 ongoing FDA recalls mention Methylphenidate (66 total). Check the affected lots below.

Recalls are matched by product description. A recall usually affects specific lots, not every package of Methylphenidate. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Methylphenidate recalls on record

none so far in 2026; 66 on record, newest first
Class III · Low risk

Ritalin HCl

Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the Package Insert for Ritalin Tablets was printed with information related to Ritalin SR (Sustained Release) Tablets. Both products, Ritalin Tablets and Ritalin SR Tablets utilize a combined Package Insert. The individual Medication Guides are attached to the Package Insert via a perforation. Although t

Terminated Labeling / mix-up Novartis Pharmaceuticals Corp. NDC 0078-0441-05 D-1228-2014
Class III · Low risk

Ritalin HCl

Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the Package Insert for Ritalin Tablets was printed with information related to Ritalin SR (Sustained Release) Tablets. Both products, Ritalin Tablets and Ritalin SR Tablets utilize a combined Package Insert. The individual Medication Guides are attached to the Package Insert via a perforation. Although t

Terminated Labeling / mix-up Novartis Pharmaceuticals Corp. NDC 0078-0440-05 D-1227-2014
Class II · Moderate risk

Daytrana (methylphenidate)

Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained.

Terminated Packaging defect Noven Pharmaceuticals, Inc. NDC 68968-5555-3 D-1172-2014
Class II · Moderate risk

Daytrana (methylphenidate)

Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained.

Terminated Packaging defect Noven Pharmaceuticals, Inc. NDC 68968-5554-3 D-1171-2014
Class II · Moderate risk

Daytrana (methylphenidate)

Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained.

Terminated Packaging defect Noven Pharmaceuticals, Inc. NDC 68968-5552-3 D-312-2013
Class II · Moderate risk

Daytrana (methylphenidate)

Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.

Terminated Packaging defect Noven Pharmaceuticals, Inc. NDC 68968-5553-3 D-1655-2012
Class II · Moderate risk

Daytrana (methylphenidate)

Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.

Terminated Packaging defect Noven Pharmaceuticals, Inc. NDC 68968-5555-3 D-1654-2012
Class II · Moderate risk

Daytrana (methylphenidate)

Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.

Terminated Packaging defect Noven Pharmaceuticals, Inc. NDC 68968-5554-3 D-1653-2012
Class II · Moderate risk

Daytrana (Methylphenidate)

Miscalibrated/Defective Delivery System; exceeded the specification for both mechanical peel force (MPF) and/or the z-statistic value

Terminated Packaging defect Noven Pharmaceuticals, Inc. NDC 68968-5554-01 D-1413-2012
Class II · Moderate risk

Daytrana (methylphenidate)

Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.

Terminated Packaging defect Noven Pharmaceuticals, Inc. NDC 54092-552-01 D-1375-2012
Class II · Moderate risk

Daytrana (methylphenidate)

Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.

Terminated Packaging defect Noven Pharmaceuticals, Inc. NDC 54092-553-01 D-1374-2012
Class II · Moderate risk

Daytrana (methylphenidate)

Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.

Terminated Packaging defect Noven Pharmaceuticals, Inc. NDC 54092-555-01 D-1373-2012
Class II · Moderate risk

Daytrana (methylphenidate)

Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.

Terminated Packaging defect Noven Pharmaceuticals, Inc. NDC 54092-554-30 D-1372-2012