Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hours, 30 recall — FDA D-0055-2025
Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
Overview of recall records associated with Noven Pharmaceuticals, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 45, Class III: 1.
Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
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 Stability Specifications; out of specification for shear.
Failed Stability Specifications; out of specification for shear.
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 release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could…
Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could…
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 results for shear, an attribute related to the adhesive properties of the transdermal patches.
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Defective Delivery System: no longer meets the specification for shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience…
Defective Delivery System: no longer meets the specification for shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience…
Defective Delivery System: Out of specification for adhesive transfer.
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
This page summarizes recall records in which the official source identifies Noven Pharmaceuticals, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.