Class I · High risk
Docetaxel Injection
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
FDA Drug Recalls
18,003 recalls, newest first
Class I · High risk
Docetaxel Injection
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Class III · Low risk
Asmanex Twisthaler
Defective Container
Class III · Low risk
Asmanex Twisthaler
Defective Container
Class III · Low risk
Asmanex Twisthaler
Defective Container
Class II · Moderate risk
Phenazopyridine HCl Tablets USP
Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Class II · Moderate risk
suntegrity
CGMP Deviations
Class I · High risk
suntegrity
Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
Class II · Moderate risk
Dexamethasone Sodium Phosphate injection USP
Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
Class II · Moderate risk
Zoledronic Acid Injection 5mg/100mL Sterile Solution
Lack of Assurance of Sterility: Leaking vials
Class II · Moderate risk
OSSOS-SANS Reforzado con: Glucosamina Curcuma Ortiga tablets
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and methocarbamol,
Class III · Low risk
Eptifibatide injection 20mg/10mL
Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
Class II · Moderate risk
Extra Strength Acetaminophen 500 MG Tablets
Discoloration: Brownish tablets
Class II · Moderate risk
Labetalol Hydrochloride Injection
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Class II · Moderate risk
Buprenorphine Hydrochloride Injection
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Class II · Moderate risk
Cathflo activase
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class III · Low risk
Tivicay PD
Labeling: Incorrect Lot and/or Expiration Date: The carton has incorrect expiration of 2026-MAY*, whereas the correct expiration date, which is on the tablet bottle label, is 2025-APR.
Class III · Low risk
Estradiol Transdermal System
Failed Impurities/Degradation Specifications.
Class III · Low risk
Estradiol Transdermal System
Failed Impurities/Degradation Specifications.
Class III · Low risk
Pregabalin Capsules 50mg
Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tablet identified as pantoprazole tablet 20mg.
Class II · Moderate risk
Eylea
Lack of Assurance of Sterility: Complaints of syringe breakage
Class II · Moderate risk
Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension
Lack of Assurance of Sterility
Class II · Moderate risk
Klarity-C (cyclosporine)
Lack of Assurance of Sterility
Class II · Moderate risk
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL…
Lack of Assurance of Sterility