Class II · Moderate risk
fentaNYL in 0.9% sodium chloride
Lack of assurance of sterility:
FDA drug recalls in 2023
Every FDA drug recall initiated in 2023, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,122 recalls, newest first.
Class II · Moderate risk
rocuronium
Lack of assurance of sterility:
Class II · Moderate risk
PHENYLephrine in 0.9% sodium chloride
Lack of assurance of sterility:
Class II · Moderate risk
PHENYLephrine in 0.9 sodium chloride
Lack of assurance of sterility:
Class II · Moderate risk
PHENYLephrine in 0.9 sodium chloride
Lack of assurance of sterility:
Class II · Moderate risk
lidocaine 2%
Lack of assurance of sterility:
Class II · Moderate risk
ePHEDrine in 0.9% sodium chloride
Lack of assurance of sterility:
Class II · Moderate risk
ketamine in 0.9% sodium chloride
Lack of assurance of sterility:
Class II · Moderate risk
fentaNYL in 0.9% sodium chloride
Lack of assurance of sterility:
Class I · High risk
Betaxolol Tablets
Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.
Class III · Low risk
MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine -…
Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.
Class III · Low risk
Eligard (leuprolide acetate)
Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.
Class I · High risk
SANDIMMUNE Oral Solution
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
Class I · High risk
TheraBreath for Kids! Oral Rinse
Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis
Class III · Low risk
Cequa (cyclosporine ophthalmic solution)
Subpotent: Out of Specification result observed for low assay
Class III · Low risk
Kroger Mint Burst ANTISEPTIC MOUTH RINSE ANTIGINGIVITIS/ANTIPLAQUE
Incorrect/Undeclared Excipients.
Class II · Moderate risk
Pantoprazole Sodium for Injection 40mg per vial
Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.
Class II · Moderate risk
octiq Lubricating Eye Drops
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes
Lack of Assurance of Sterility
Class II · Moderate risk
MAJOR LubriFresh P.M. Nighttime Ointment
Lack of Assurance of Sterility