Class II · Moderate risk Ongoing
Wegovy
Reason Presence of Particulate Matter: Hair was found in a prefilled syringe
FDA Drug Recalls
2,661 recalls, newest first
Class II · Moderate risk Ongoing
Wegovy
Reason Presence of Particulate Matter: Hair was found in a prefilled syringe
Class II · Moderate risk Ongoing
Tri-Moxi+¿
Reason Presence of particulate matter - Glass like particles.
Class II · Moderate risk Ongoing
Dexamethasone Moxifloxacin Ketorolac
Reason Presence of particulate matter - Glass like particles.
Class II · Moderate risk Ongoing
Dexamethasone Moxifloxacin
Reason Presence of particulate matter - Glass like particles.
Class II · Moderate risk Ongoing
BD ChloraPrep" Triple Swabsticks
Reason Lack of Assurance of Sterlity
Class II · Moderate risk Ongoing
Oxycodone and Acetaminophen CII Tablets USP
Reason Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Class II · Moderate risk Ongoing
Oxycodone and Acetaminophen CII Tablets USP
Reason Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Class III · Low risk Ongoing
Fesoterodine Fumarate
Reason Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Class I · High risk Ongoing
MR. 7 SUPER 700000 capsules
Reason Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil
Class III · Low risk Ongoing
Glycopyrrolate Oral Solution
Reason Failed Impurities/Degradation Specifications
Class I · High risk Ongoing
ClearLife Allergy Nasal Spray
Reason Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
Class I · High risk Ongoing
ReBoost Nasal Spray
Reason Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
Class II · Moderate risk Ongoing
Noxafil Powdermix
Reason Presence of particulate matter: potential presence of metal particulates in the product.
Class II · Moderate risk Ongoing
Merck Emend
Reason Presence of particulate matter: potential presence of metal particulates in the product.
Class II · Moderate risk Ongoing
Ciclopirox Shampoo
Reason Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
Class II · Moderate risk Ongoing
ORL Kids Natural Toothpaste
Reason cGMP Deviations
Class II · Moderate risk Ongoing
ORL Kids Mouthwash
Reason cGMP Deviations
Class III · Low risk Ongoing
Clindamycin Phosphate USP
Reason Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
Class III · Low risk Ongoing
Cisatracurium Besylate Injection USP
Reason Subpotent product:out of specification assay results observed during long term stability testing.
Class III · Low risk Ongoing
Cisatracurium Besylate Injection USP
Reason Subpotent product:out of specification assay results observed during long term stability testing.
Class III · Low risk Ongoing
Cisatracurium Besylate Injection USP
Reason Subpotent product:out of specification assay results observed during long term stability testing.
Class II · Moderate risk Ongoing
Baclofen Tablets USP
Reason Presence of Foreign Tablets/Capsules
Class III · Low risk Ongoing
Morphine Sulfate Oral Solution 100 mg / 5 mL
Reason Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules
Reason CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit