316 recalls, newest first
Reason Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Reason Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed…
Reason Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed…
Reason Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed…
Reason Failed Dissolution Specifications
Reason Sub-potent Drug: Lower potency than labeled.
Reason Presence of Particulate Matter: Silicone
Reason Presence of Particulate Matter: Silicone
Reason Presence of Particulate Matter: Silicone
Reason Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is…
Reason Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with Sildenafil an ingredient found in an FDA approved product…
Reason CGMP Deviations: OTC products were stored outside of labeled temperature requirements.
Reason Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required…
Reason Presence of Particulate Matter: A product complaint of a piece of glass was identified in a vial. The piece of glass appears to be roughly 1 cm x 0.5…
Reason Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two tablets demonstrating illegible tablet…
Reason Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
Reason Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility