Direct Rx Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg recall — FDA D-0041-2025
Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
Browse the newest complete recall records currently stored from FDA enforcement reports and NHTSA vehicle campaigns. “Latest” refers to the newest source-dated record in this database, not the timestamp of our last API check.
The newest recall records with useful source details are listed here.
Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
BMW of North America, LLC (BMW) is recalling certain 2025 X3 30 xDrive vehicles. The gas generator in the right-side head curtain air bag may have been assembled incorrectly.
Ford Motor Company (Ford) is recalling certain 2024-2025 Escape vehicles. The passenger side instrument panel cover may have been manufactured incorrectly, which can cause the air bag not…
Ford Motor Company (Ford) is recalling certain 2020-2025 Explorer, Lincoln Aviator, 2020-2024 Escape, Lincoln Corsair, 2018-2024 F-150, Expedition and Lincoln Navigator vehicles. The air…
Hyundai Motor America (Hyundai) is recalling certain 2024 Santa Fe and Santa Fe Hybrid vehicles. The overhead console rear sunshade switch knob may not be fully recessed, which can result…
Chrysler (FCA US, LLC) is recalling certain 2018-2019 Jeep Grand Cherokee and Dodge Durango vehicles. A malfunction in the antilock-brake system (ABS) module may incorrectly illuminate the…
Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.
Does not meet the requirements for electromagnetic compatibility (EMC) of the standard IEC 60601-1-2. Electromagnetic interference occurring during a procedure may cause the device to…
Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.
Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of…
Due to packaging damage from heat exposure during shipping/transportation that may result in a breach in the sterile barrier.
Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of…
Prior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from newly manufactured incubators could be seen during clinical use that would rapidly…
Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of…
Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of…
Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of…
Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.
Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.
Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label.
Due to connector within the circuit flex extender not meeting specifications resulting in a low connection force and as a result, the connector may leak or disconnect and may cause life…
Due to an out of tolerance tool being used on monitor/defibrillator systems.
Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of…
Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of…
Browse recent months with enough recall history for useful comparison.