Methylphenidate Hydrochloride
Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
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.
Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
Presence of Foreign Substance: Metal embedded in a tablet.
Defective Delivery System: Out of specification for shear.
Defective Delivery System: Out of specification for shear.
Defective Delivery System: Out of specification for shear.
Defective Delivery System: Out of specification for shear.
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.
Defective Delivery System: Customer complaints received for ripping patches and tight release/adhesive transfer.
Defective Delivery System: customer complaints exceeded respective action limits.
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.
Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.
Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.
Defective Delivery System: Out of specification for mechanical peel.
Defective Delivery System: Out of specification for mechanical peel.
Defective Delivery System: Out of specification for mechanical peel.
Defective Delivery System: Out of specification for mechanical peel.
Defective Delivery System: Out of specification for mechanical peel and shear.
Defective Delivery System: Out of specification for mechanical peel and shear.
Defective Delivery System: Out of specification for mechanical peel and shear.
Defective Delivery System: Out of specification for mechanical peel and shear.
Defective Delivery System: Out of specification for mechanical peel and shear.
Defective Delivery System: Out of specification for mechanical peel and shear.
Defective Delivery System: Out of specification for mechanical peel and shear.
CGMP deviations: Product bottle may be absent of desiccant.
CGMP deviations: Product bottle may be absent of desiccant.
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