Class II · Moderate risk
Nystatin 150 Mu
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
FDA Drug Recalls
11 recalls, newest first
Class II · Moderate risk
Nystatin 2 Bu
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class II · Moderate risk
Nystatin 500 Mu
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class II · Moderate risk
Nystatin 5bu
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
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
Class II · Moderate risk
Naproxen Tablets
Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
Class II · Moderate risk
Indomethacin 25mg Capsules
Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
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
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
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.