Class III · Low risk
LET Gel
Product Mix-up: Incorrect Product Formulation
FDA Drug Recalls
28 recalls, newest first
Class III · Low risk
VANCOmycin HCI PF
Labeling: Not Elsewhere Classified
Class III · Low risk
VANCOmycin HCI PF
Labeling: Not Elsewhere Classified
Class III · Low risk
Oxytocin synthetic
Labeling: Not Elsewhere Classified
Class III · Low risk
Clearasil Rapid Rescue Deep Treatment Pads
Labeling: Label Error on Declared Strength: The incorrect label on the back of the product packaging.
Class II · Moderate risk
Digoxin Tablets
Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tablets, USP 0.125mg.
Class I · High risk
Digoxin Tablets
Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tablets, USP 0.125mg.
Class II · Moderate risk
Capsaicin Cream 0.025%
Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste
Class II · Moderate risk
Sodium Fluoride 1.1%
Cases of Sodium Fluoride 1.1% Prescription Dental Toothpaste may contain cartons labeled as Capsaicin Cream 0.025% but contain correctly labeled tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste
Class II · Moderate risk
hello wild strawberry fluoride toothpaste
Labeling: Label Mix-Up: Some hello wild strawberry fluoride toothpaste, packaged in cartons labeled as hello wild strawberry fluoride toothpaste were incorrectly filled in tubes labeled as hello fresh watermelon fluoride free toothpaste.
Class III · Low risk
Pluvicto 1
Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date
Class III · Low risk
0.9% Sodium Chloride Injection USP
Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed.
Class III · Low risk
Glycopyrrolate Injection
Labeling: Label Mix-up
Class I · High risk
ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg
Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and containing Dronabinol Capsules, USP, 2.5 mg.
Class III · Low risk
Methylprednisolone Acetate Injectable Suspension
Labeling: Not Elsewhere Classified; A typographical error was observed in the NDC number on the preprinted Individual Folding Cartons (secondary packaging only). Incorrect NDC Number 70121-1573-1; Correct NDC Number 70121-1574-1.
Class II · Moderate risk
Famotidine Tablets
Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton indicating strength as 10 mg.
Class III · Low risk
Fentanyl Buccal Tablets CII
Labeling: Incorrect or Missing Package Insert
Class III · Low risk
Fentanyl Buccal Tablets CII
Labeling: Incorrect or Missing Package Insert
Class III · Low risk
Fentanyl Buccal Tablets CII
Labeling: Incorrect or Missing Package Insert
Class III · Low risk
Fentanyl Buccal Tablets CII
Labeling: Incorrect or Missing Package Insert
Class III · Low risk
Fentanyl Buccal Tablets CII
Labeling: Incorrect or Missing Package Insert
Class III · Low risk
Gabapentin Tablets
Product mixup: one foreign tablet found in product.
Class I · High risk
G-Supress DX
Product mix-up: incorrect product was found inside the G-Supress DX product carton.
Class III · Low risk
Bevacizumab 2.5 mg/0.1 mL
Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect.
Class II · Moderate risk
JARDIANCE (Empagliflozin)
Labeling: Label Mix-up