0.9% recall 2026
Product mix-up where 0.9% Sodium Chloride Injection, USP overwrap may contain 10 mEq Potassium Chloride Injection
FDA enforcement data, made searchable
Search recent United States drug recall enforcement records by name, brand, NDC, manufacturer, recall number, or lot and code information.
Independent tool | Data sourced from openFDA | Not an FDA service or medical advice
Coverage: September 23, 2024 to September 23, 2026. Dataset last checked Sep 23, 2026 UTC.
Current FDA topics
Server-rendered and checked against FDA sources
Product mix-up where 0.9% Sodium Chloride Injection, USP overwrap may contain 10 mEq Potassium Chloride Injection
Presence of particulate matter identified as cellulose or stopper material
Elevated Endotoxin level
The firmware version, G3-2.00.76 installed on the Luna G3 APAP (Model LG3600) devices contained a firmware defect
Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)
Presence of particulate matter identified as zinc oxide.
Potential presence of particulate matter identified as fiberglass in the solution.
Potential presence of particulate matter identified as stainless steel particles in the solution.
Potential presence of particulate matter identified as fiberglass in the solution
Potential for the Product to be Superpotent
Elevated Endotoxin level
Presence of particulate matter identified primarily as cellulose cotton fibers, with individual particles also identified as cellulose wood fiber and polystyrene
Due to Presence of Glass Particles
Elevated Endotoxin level
Due to a label mix-up
Presence of particulate matter comprising polyethylene and other plastic materials, stainless steel and glass
Visible glass fiber material in the product
Products were found to contain particulate matter
Particulate matter identified as cardboard was found in the solution.
Particulate matter identified as steel was found in the product.
Potential cross contamination with ranitidine.
Potential risk of Clostridium botulinum contamination.
Searches for a levothyroxine recall are being driven in part by an FDA action concerning unapproved animal-derived thyroid medications, not a blanket recall of synthetic levothyroxine.
Latest records
1,531 records in the current dataset
Ajanta Pharma USA Inc
Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0 percent.
Baxter Healthcare Corporation
Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
Baxter Healthcare Corporation
CGMP Deviations