Class I · High risk
Gaia Kratom
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
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 I · High risk
Gaia Kratom
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk
Gaia Kratom
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk
Gaia Kratom
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk
Gaia Kratom
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class II · Moderate risk
fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL
Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated on the label.
Class III · Low risk
Enalapril Maleate Tablets USP
Failed Impurities/Degradation Specifications
Class III · Low risk
Enalapril Maleate Tablets USP
Failed Impurities/Degradation Specifications
Class III · Low risk
Rocaltrol (calcitriol)
Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
Class III · Low risk
Calcitriol Oral Solution
Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
Class II · Moderate risk
Phenylephrine HCL 80mg in 0.9% Sodium Chloride 250 mL Bag
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class II · Moderate risk
Phenylephrine HCL 50 mg in 0.9% Sodium Chloride 250 mL Bag
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class II · Moderate risk
Phenylephrine HCL 20 mg in 0.9% Sodium Chloride 250 mL Bag
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class II · Moderate risk
Phenylephrine HCL 40 mg in 0.9% Sodium Chloride 250 mL Bag
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class II · Moderate risk
Phenylephrine HCL 10 mg in 0.9% Sodium Chloride 250 mL Bag
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class II · Moderate risk
Norepinephrine Bitartrate 16 mg
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class II · Moderate risk
Norepinephrine Bitartrate 8 mg
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class II · Moderate risk
Norepinephrine Bitartrate 4 mg
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class II · Moderate risk
Diltiazem HCL 1 mg/mL in 125 mL 0.9% Sodium Chloride 100 mL bag
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class II · Moderate risk
Fentanyl (as citrate)
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class II · Moderate risk
Fentanyl (as citrate)
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class II · Moderate risk
Morphine Sulfate 1 mg/mL
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class III · Low risk
Equate ClearLAX
Labeling: Not Elsewhere Classified - A private label distributor noted unfiled NDC numbers on EQ ClearLax Polyethylene Glycol 3350 NF Powder Solution of various sizes.
Class II · Moderate risk
PHENYLephrine 10 mg
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
ePHEDrine Sulfate
Lack of Assurance of Sterility: Potential leakage of bags.