Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug: Assay below the approved specification
FDA Drug Recalls
721 recalls, newest first
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug: Assay below the approved specification
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug: Assay below the approved specification
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug: Assay below the approved specification
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug: Assay below the approved specification
Class II · Moderate risk
Gabapentin Capsules
Defective container; blister packaging inadequately sealed.
Class II · Moderate risk
Gabapentin Capsules
Defective container; blister packaging inadequately sealed.
Class III · Low risk
Testosterone 200 mg Pellet packaged in 1mL amber vials
Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.
Class II · Moderate risk
Lisdexamfetamine Dimesylate Capsules
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH).
Class II · Moderate risk
0.9% Sodium Chloride Injection USP
Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
Class III · Low risk
Pitavastatin Tablets
Failed Impurities/Degradation Specifications.
Class III · Low risk
Pitavastatin Tablets
Failed Impurities/Degradation Specifications.
Class III · Low risk
Famciclovir Tablets
Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
Class II · Moderate risk
KIMMTRAK (tebentafusp-tebn)
Subpotent Drug
Class I · High risk
Orajel Baby
Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.
Class I · High risk
Zicam Nasal Allclear
Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
Class I · High risk
Zicam Cold Remedy Medicated Nasal Swabs
Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
Class II · Moderate risk
LIDOcaine HCL Sterile Injection
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II · Moderate risk
LIDOcaine HCL Sterile Injection
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II · Moderate risk
KETAmine Hydrochloride Injection
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II · Moderate risk
KETAmine Hydrochloride Injection
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II · Moderate risk
BUPIVAcaine HCL Sterile injection
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II · Moderate risk
LIDOcaine HCl Injection
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class I · High risk
Sulfamethoxazole and Trimethoprim Tablets
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
Class II · Moderate risk
Testo-200
Marketed Without an Approved NDA/ANDA