Class II · Moderate risk
Children's Grape Flavored Acetaminophen Oral Suspension
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Children's Grape Flavored Acetaminophen Oral Suspension
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk
Acetaminophen Child Dye Free Cherry Flavor Oral Suspension
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk
Acetaminophen Child Dye Free Cherry Flavor Oral Suspension
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk
Acetaminophen Child Dye Free Cherry Flavor Oral Suspension
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk
Acetaminophen Child Dye Free Cherry Flavor Oral Suspension
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk
Infant's Grape Flavored Acetaminophen Oral Suspension
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk
Acetaminophen Infant Dye Free Grape Oral Suspension
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk
Acetaminophen Child Strawberry Oral Suspension
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk
Children's Cherry Flavored Acetaminophen Oral Suspension
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk
Children's Grape Flavored Acetaminophen Oral Suspension
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk
Children's Pain & Fever Bubblegum Flavored Acetaminophen Suspension
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk
Acetaminophen Oral Suspension Grape Flavor
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class III · Low risk
Topiramate Tablets
Discoloration
Class II · Moderate risk
Tadalafil Tablets
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
Class II · Moderate risk
Tadalafil Tablets
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
Class II · Moderate risk
Pregabalin Capsules
Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.
Class III · Low risk
Gatifloxacin Ophthalmic Solution
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
Class II · Moderate risk
Diclofenac Sodium Topical Solution USP
Defective Container
Class II · Moderate risk
Diclofenac Sodium Topical Solution USP
Defective Container
Class I · High risk
Cubicin (daptomycin for injection)
Presence of Particulate Matter: Identified as Glass Particles
Class III · Low risk
Rizatriptan Benzoate Orally Disintegrating Tablets 10mg
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Class III · Low risk
Rizatriptan Benzoate Orally Disintegrating Tablets 5mg
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Class III · Low risk
Rizatriptan Benzoate Film Coated Tablets
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Class II · Moderate risk
Ezetimibe and Simvastatin Tablets
Failed Excipient Specification; product manufactured using an excipient found to be OOS for conductivity