Complete FDA and NHTSA recall records dated in November 2025.
These records include useful source details for the selected month.
There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage…
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage…
Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axial scan…
Potential for a weak seal in some units resulting in compromise in sterility.
Undeclared Tree Nut. The firm discovered that Hazelnuts was not listed in the allergen statement
Undeclared Peanuts. The firm received two complaints that the product contains peanuts which are not listed in the ingredient statement.
Undeclared Tree Nut. The firm discovered that Hazelnuts was not listed in the allergen statement
undeclared milk allergen
undeclared milk allergen
Undeclared allergen ingredient (Wheat) in Ready-to-eat frozen cakes.
Undeclared allergen ingredient (Wheat) in Ready-to-eat frozen cakes.
Undeclared shrimp
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.
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.
