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.

Most common reason: Packaging defect (45 of these recalls)

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 in 2026

1 initiated in 2026, 66 in total — newest first
Class II · Moderate risk

Methylphenidate Hydrochloride

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

Terminated Dissolution failure Trigen Laboratories NDC 13811-708-10 D-0579-2024
Class II · Moderate risk

Daytrana (methylphenidate transdermal system)

Defective Delivery System: Recalled lot was found to be out of specification for shear. Shear is an attribute related to the adhesive properties of the transdermal patches.

Ongoing Packaging defect Noven Pharmaceuticals Inc NDC 68968-5553-3 D-0071-2023
Class II · Moderate risk

Methylphenidate Hydrochloride Chewable Tablets

Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufacturer due to a market complaint, which stated that a tablet in the sealed bottle was twice larger in size when compared to the remaining tablets. This complaint is second of its kind.

Ongoing Failed specification Rising Pharmaceuticals NDC 64980-221-01 D-0573-2022
Class II · Moderate risk

Daytrana (methylphenidate transdermal system)

Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.

Ongoing Packaging defect Noven Pharmaceuticals Inc NDC 68968-5553-1 D-0394-2021
Class II · Moderate risk

Daytrana (methylphenidate transdermal system)

Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.

Ongoing Packaging defect Noven Pharmaceuticals Inc NDC 68968-5552-1 D-0393-2021