Class II · Moderate risk
fentaNYL Citrate PF 200 mcg/100 mL
Lack of Assurance of Sterility
FDA Drug Recalls
692 recalls, newest first
Class II · Moderate risk
fentaNYL Citrate PF 200 mcg/100 mL
Lack of Assurance of Sterility
Class I · High risk
BD ChloraPrep Clear 1mL Applicators
Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
Class II · Moderate risk
ViaMed Alcohol Prep Pads
Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.
Class I · High risk
Systane Lubricant Eye Drops
Non-Sterility
Class II · Moderate risk
Refresh LACRI-LUBE
Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Class II · Moderate risk
Refresh P.M.
Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Class II · Moderate risk
TIRZEPATIDE 60 mg/3mL
Lack of Assurance of Sterility
Class II · Moderate risk
TIRZEPATIDE 20 mg/2mL
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide / Cyanocobalamin Injection: 2.5/0.5 mg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
SEMAGLUTIDE 10mg/4mL
Lack of Assurance of Sterility
Class II · Moderate risk
SEMAGLUTIDE 5mg/2mL
Lack of Assurance of Sterility
Class II · Moderate risk
Tirzepatide 2 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Dianeal Low Calcium
Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.
Class II · Moderate risk
Zoledronic Acid Injection 5mg/100mL Sterile Solution
Lack of Assurance of Sterility: Leaking vials
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
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
Class II · Moderate risk
Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials…
Lack of Assurance of Sterility
Class II · Moderate risk
Moxifloxacin 0.8 mg/0.8 mL Preservative-Free 0.8mL Single-Use…
Lack of Assurance of Sterility
Class II · Moderate risk
Dexamethasone-Moxifloxacin- Ketorolac
Lack of Assurance of Sterility