Browse Drug Recalls

51 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 51 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 51 FDA drug recalls.

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DateProductReasonClassFirm
Oct 31, 2024 Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 ... Defective Delivery System: The product does not meet predetermined specifications for Coldflow (a... Class II Noven Pharmaceuticals Inc
Mar 10, 2023 Daytrana (methylphenidate transdermal system) CII, 20mg, 30-count carton, Rx ... Defective Delivery System: Out of specification for shear. Class II Noven Pharmaceuticals Inc
Mar 10, 2023 Daytrana (methylphenidate transdermal system) CII, 15 mg, 30-count carton, Rx... Defective Delivery System: Out of specification for shear. Class II Noven Pharmaceuticals Inc
Mar 10, 2023 Daytrana (methylphenidate transdermal system) CII, 10mg, 30-count carton, Rx ... Defective Delivery System: Out of specification for shear. Class II Noven Pharmaceuticals Inc
Mar 10, 2023 Daytrana (methylphenidate transdermal system) CII, 30 mg, 30-count carton, Rx... Defective Delivery System: Out of specification for shear. Class II Noven Pharmaceuticals Inc
Nov 16, 2022 Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours, (... Defective Delivery System: Recalled lot was found to be out of specification for shear. Shear is ... Class II Noven Pharmaceuticals Inc
Jun 24, 2022 Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.... Defective Delivery System: Customer complaints received for ripping patches and tight release/adh... Class II Noven Pharmaceuticals Inc
May 6, 2022 Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.... Defective Delivery System: customer complaints exceeded respective action limits. Class II Noven Pharmaceuticals Inc
Jul 30, 2021 Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg ... Failed Stability Specifications; out of specification for shear. Class II Noven Pharmaceuticals Inc
Jul 30, 2021 Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg ... Failed Stability Specifications; out of specification for shear. Class II Noven Pharmaceuticals Inc
May 20, 2021 Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1... Defective Delivery System: The number of customer complaints for ripping patches and tight releas... Class II Noven Pharmaceuticals Inc
May 20, 2021 Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1... Defective Delivery System: The number of customer complaints for ripping patches and tight releas... Class II Noven Pharmaceuticals Inc
Apr 16, 2021 Minivelle (estradiol transdermal system) Delivers 0.075 mg/day, 8 patches/box... Defective Delivery System: Out of specification for release rate testing and shear, an attribute ... Class II Noven Pharmaceuticals Inc
Apr 16, 2021 Estradiol Transdermal System Delivers 0.0375 mg/day, 8 Systems/box, Rx only, ... Defective Delivery System: Out of specification for release rate testing and shear, an attribute ... Class II Noven Pharmaceuticals Inc
Feb 19, 2021 Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.... Defective Delivery System: Out of specification for mechanical peel. Class II Noven Pharmaceuticals Inc
Feb 19, 2021 Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1... Defective Delivery System: Out of specification for mechanical peel. Class II Noven Pharmaceuticals Inc
Feb 19, 2021 Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1... Defective Delivery System: Out of specification for mechanical peel. Class II Noven Pharmaceuticals Inc
Feb 19, 2021 Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.... Defective Delivery System: Out of specification for mechanical peel. Class II Noven Pharmaceuticals Inc
Sep 7, 2018 Minivelle (estradiol transdermal system) Patches, Delivers 0.05 mg/day, a) 2 ... Defective Delivery System: out of specification results for shear, an attribute related to the ad... Class II Noven Pharmaceuticals, Inc.
Sep 7, 2018 Minivelle (estradiol transdermal system) Patches, Delivers 0.075 mg/day, 8 co... Defective Delivery System: out of specification results for shear, an attribute related to the ad... Class II Noven Pharmaceuticals, Inc.
Sep 7, 2018 Minivelle (estradiol transdermal system) Patches Delivers 0.1 mg/day, a) 2 co... Defective Delivery System: out of specification results for shear, an attribute related to the ad... Class II Noven Pharmaceuticals, Inc.
Sep 7, 2018 Minivelle (estradiol transdermal system) Patches, Delivers 0.025 mg/day, 8 co... Defective Delivery System: out of specification results for shear, an attribute related to the ad... Class II Noven Pharmaceuticals, Inc.
May 4, 2018 Minivelle (estradiol transdermal system) 0.0375 mg/day, 1 System per pouch (N... Defective Delivery System: no longer meets the specification for shear, an attribute related to t... Class II Noven Pharmaceuticals, Inc.
May 4, 2018 Minivelle (estradiol transdermal system) 0.1 mg/day, 1 System per pouch (NDC ... Defective Delivery System: no longer meets the specification for shear, an attribute related to t... Class II Noven Pharmaceuticals, Inc.
Apr 9, 2018 Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.... Defective Delivery System: Out of specification for adhesive transfer. Class II Noven Pharmaceuticals, Inc.
Aug 30, 2017 Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.... Defective Delivery System: Products no longer meet the release liner removal specification and/or... Class II Noven Pharmaceuticals, Inc.
Aug 30, 2017 Daytrana (methylphenidate transdermal system) Delivers 15 mg over 9 hours (1.... Defective Delivery System: Products no longer meet the release liner removal specification and/or... Class II Noven Pharmaceuticals, Inc.
Aug 30, 2017 Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.... Defective Delivery System: Products no longer meet the release liner removal specification and/or... Class II Noven Pharmaceuticals, Inc.
Aug 30, 2017 Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.... Defective Delivery System: Products no longer meet the release liner removal specification and/or... Class II Noven Pharmaceuticals, Inc.
Apr 27, 2017 Minivelle (estradiol Transdermal System) 0.1 mg per day, pack of 8 systems pe... Defective Delivery System: Out of specification for peel force from the release liner specificati... Class III Noven Pharmaceuticals, Inc.
Aug 22, 2016 Daytrana (methylphenidate transdermal system) Transdermal Patch, 10 mg over 9... Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF)... Class II Noven Pharmaceuticals, Inc.
Aug 22, 2016 Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9... Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF)... Class II Noven Pharmaceuticals, Inc.
Aug 22, 2016 Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9... Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF)... Class II Noven Pharmaceuticals, Inc.
Dec 21, 2015 Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9... Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF)... Class II Noven Pharmaceuticals, Inc.
Dec 21, 2015 Daytrana (methylphenidate transdermal system) Transdermal Patch, 15 mg over 9... Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF)... Class II Noven Pharmaceuticals, Inc.
Dec 21, 2015 Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9... Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF)... Class II Noven Pharmaceuticals, Inc.
Jul 27, 2015 Daytrana (methylphenidate transdermal system), 30 mg over 9 Hour Patches (3.3... Defective Delivery System: Out of specification for z-statistic related to mechanical peel force. Class II Noven Pharmaceuticals, Inc.
Feb 25, 2015 Minivelle (estradiol transdermal system) 0.05 mg/day, 8-count box, Rx only, M... Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions. Class II Noven Pharmaceuticals, Inc.
Jan 12, 2015 Daytrana (methylphenidate transdermal system), Delivers 30 mg over 9 hours (3... Defective Delivery System: One lot exceeded the mechanical peel specification Class II Noven Pharmaceuticals, Inc.
Jul 15, 2014 Daytrana (methylphenidate transdermal system) patch, Delivers 20 mg over 9 ho... Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF)... Class II Noven Pharmaceuticals, Inc.
Feb 13, 2014 Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 ho... Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which re... Class II Noven Pharmaceuticals, Inc.
Feb 13, 2014 Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 ho... Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which re... Class II Noven Pharmaceuticals, Inc.
Jan 31, 2013 Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 ho... Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which re... Class II Noven Pharmaceuticals, Inc.
Jul 12, 2012 Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 ho... Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel ... Class II Noven Pharmaceuticals, Inc.
Jul 12, 2012 Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 ho... Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel ... Class II Noven Pharmaceuticals, Inc.
Jul 12, 2012 Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 ho... Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel ... Class II Noven Pharmaceuticals, Inc.
Mar 22, 2012 Daytrana (Methylphenidate) Transdermal System Patch, Delivers 20 mg over 9 ho... Miscalibrated/Defective Delivery System; exceeded the specification for both mechanical peel forc... Class II Noven Pharmaceuticals, Inc.
Jul 5, 2011 Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 ho... Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel ... Class II Noven Pharmaceuticals, Inc.
Jul 5, 2011 Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 ho... Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel ... Class II Noven Pharmaceuticals, Inc.
Jul 5, 2011 Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 ho... Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel ... Class II Noven Pharmaceuticals, Inc.

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.