Class III · Low risk
Fentanyl 1000mcg/100mL
Labeling: Wrong Barcode
FDA Drug Recalls
9 recalls, newest first
Class I · High risk
Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free
Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.
Class II · Moderate risk
Adrenalin (epinephrine)
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.
Class III · Low risk
Bendamustine HCl Injection
Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
Class II · Moderate risk
Ascorbic Acid Preserved Injection Solution
Mislabeling: preservative free product labeled as preserved.
Class III · Low risk
Crest 3D White Fluoride Anticavity Toothpaste
Labeling: Missing label: the product tube was missing a label and contained a different formulation.
Class I · High risk
AmericanScreening HAND SANITIZER
Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.
Class I · High risk
Methocarbamol 500mg Tablet
Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actually contain Methocarbamol 750 mg Tablets
Class II · Moderate risk
Drospirenone and Ethinyl Estradiol Tablets
Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement.