Mesalamine Extended-Release Capsules, USP 500mg recall — FDA D-0350-2024
Failed Dissolution Specifications: Out of specification for dissolution.
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 Dissolution Specifications: Out of specification for dissolution.
Nissan North America, Inc. (Nissan) is recalling certain 2024 Pathfinder and Infiniti QX60 vehicles. The lap belt pretensioner in the left-side front seat belt assembly may be improperly…
Nissan North America, Inc. (Nissan) is recalling certain 2023 Rogue vehicles. The driver and front passenger seat belt pretensioners may have been incorrectly manufactured, which can cause…
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual…
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male…
Failed Impurities/Degradation Specification: Out of specification for organic impurities
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.
CGMP Deviations: potential presence of Burkholderia cepacia complex
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Chemical Contamination; presence of benzene.
Labeling: Incorrect or Missing Package Insert
Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the primary bag label correctly identified…
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male…
CGMP Deviations: Potential Glass and Silicone particulates in product
CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.
Toyota Motor Engineering & Manufacturer (Toyota) is recalling certain 2022-2023 Tacoma vehicles. The axle shaft sub-assembly may separate from the axle housing due to debris causing…
Nissan North America, Inc. (Nissan) is recalling certain 2024 Titan, Frontier, Infiniti QX60, Pathfinder, 2023-2024 Sentra, Versa, Kicks, Infiniti QX50, and 2023 Rogue vehicles. Due to a…
Tesla, Inc. (Tesla) is recalling certain 2013, 2018-2021 Model S, 2020-2021 Model X, 2018-2022 Model 3, and 2020-2022 Model Y vehicles. A factory reset muted the Pedestrian Warning System…
Kia America, Inc. (Kia) is recalling certain 2020 Telluride vehicles. The high beam headlights may fail.
Ford Motor Company (Ford) is recalling certain 2022-2023 Maverick Hybrid vehicles. The Instrument Panel Cluster may not properly illuminate warning lights or gauges. As such, these vehicles…
Ford Motor Company (Ford) is recalling certain 2023-2024 Bronco and Bronco Heritage vehicles. The rear quarter glass panels may have been improperly installed to the vehicle hard top, which…
Browse recent months with enough recall history for useful comparison.