Class III · Low risk
Tropicamide 1%
Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL single-use syringe instead of a 5 mL dropper
FDA Drug Recalls
24 recalls · Class III, newest first
Class III · Low risk
LET Gel
Product Mix-up: Incorrect Product Formulation
Class III · Low risk
Synthroid
Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is scanned as 200mcg unit dose.
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 III · Low risk
Bendamustine HCl Injection
Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
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 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 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 III · Low risk
Lidocaine Patch 5%
Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each tablet contains instead of each adhesive patch contains.
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 III · Low risk
Epinephrine Professional EMS
Labeling; Incorrect NDC number on outer carton of product.
Class III · Low risk
MEKTOVI (binimetinib)
Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry date of March 2026; the correct expiration date is February 2025.
Class III · Low risk
Dibucaine 1% Hemorrhoidal Ointment
Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk
Levofloxacin Tablets
Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.