Class II · Moderate risk
Testosterone/Finasteride 60 mg/5 mg pellet Amber vial
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
FDA drug recalls in 2018
Every FDA drug recall initiated in 2018, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,681 recalls, newest first.
Class II · Moderate risk
Testosterone/Estradiol 60 mg/6 mg pellet Amber vial
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk
Testosterone/Anastrozole 120 mg/8 mg pellets packaged in amber vial
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk
Progesterone 50 mg
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk
Pregnenolone 100 mg
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk
Naltrexone 200 mg pellet
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk
Methionine 25mg/Inositol 50mg/Choline 50mg/ B12 1mg
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk
Vitamin D 50
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk
TM #1 (Alp 5.9/Papav 17.65/Phen 0.59)
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk
Testosterone Cypionate 200mg/mL
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk
Nandrolone decanoate 200mg/mL
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk
Methionine 25mg/Inositol 50mg/Choline 50mg/ B12 1mg
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk
Methionine15mg/Inositol 50mg/Choline 100mg
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk
Lipoic Acid 25mg/mL
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk
HCG 1000 units/mL
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk
Glutathione 200mg/mL
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk
CoEnzymeQ10 25mg/mL
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk
Biotin Suspension 10mg/mL
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk
B-complex (B1-200mg, B2-4mg, B3-200mg,B5-4mg,B6-4mg)
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk
Ascorbic Acid
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class III · Low risk
Fabior (tazarotene)
Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point.
Class III · Low risk
Tramadol Hydrochloride 50 mg tablets
Labeling: Incorrect or Missing Lot and/or Exp Date
Class II · Moderate risk
Estradiol Vaginal Inserts
Defective Container: This recall is being initiated due to product complaints regarding difficulty in dispensing the tablet from the applicator.
Class III · Low risk
Indomethacin Capsules USP
Labeling: Incorrect Instructions: bottles incorrectly labeled with the usual adult dosage of "One or two capsules 2 or 3 times a day." rather than the correct usual adult dosage of "One capsule 2 or 3 times a day.
Class I · High risk
All Alka-Seltzer Plus¿ packages with a full front panel instant Redeemable Coupon
Labeling: Label Mix-Up: Bayer is recalling all Alka-Seltzer Plus packages, with a green or orange Bayer logo located on the lower left corner of the front of the carton, because the ingredients on the front sticker may not match the actual product in the carton.