Complete FDA and NHTSA recall records dated in November 2025.
These records include useful source details for the selected month.
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25C, 60%RH) for Lisdexamfetamine…
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25C, 60%RH) for Lisdexamfetamine…
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25C, 60%RH) for Lisdexamfetamine…
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25C, 60%RH) for Lisdexamfetamine…
Presence of Particulate Matter
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25C, 60%RH) for Lisdexamfetamine…
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25C, 60%RH) for Lisdexamfetamine…
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Lack of Assurance of Sterility.
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25C, 60%RH) for Lisdexamfetamine…
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
