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

Aptensio XR

Failed Dissolution Specification: Low dissolution outside of specifications

Terminated Dissolution failure Rhodes Pharmaceuticals, L.P. NDC 42858-402-45 D-0710-2018
Class III · Low risk

Quillivant XR

Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.

Terminated Dissolution failure Pfizer Inc NDC 24478-190-30 D-0609-2017
Class III · Low risk

Quillivant XR

Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.

Terminated Dissolution failure Pfizer Inc NDC 24478-205-25 D-0608-2017
Class III · Low risk

Quillivant XR

Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.

Terminated Dissolution failure Pfizer Inc NDC 24478-190-10 D-0607-2017
Class II · Moderate risk

Daytrana (methylphenidate transdermal system)

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

Terminated Packaging defect Noven Pharmaceuticals, Inc. NDC 68968-5555-3 D-1440-2016
Class II · Moderate risk

Daytrana (methylphenidate transdermal system)

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

Terminated Packaging defect Noven Pharmaceuticals, Inc. NDC 68968-5554-3 D-1439-2016
Class II · Moderate risk

Daytrana (methylphenidate transdermal system)

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

Terminated Packaging defect Noven Pharmaceuticals, Inc. NDC 68968-5553-3 D-1438-2016
Class II · Moderate risk

Daytrana (methylphenidate transdermal system)

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

Terminated Packaging defect Noven Pharmaceuticals, Inc. NDC 68968-5554-3 D-1608-2014