Class III · Low risk Terminated
Jolessa
Reason Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.
FDA Drug Recalls
1,709 recalls · Class III, newest first
Class III · Low risk Terminated
Portia
Reason Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.
Class III · Low risk Terminated
Acetic Acid Otic Solution
Reason Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the 18-month test station.
Class III · Low risk Terminated
4 way Saline Moisturizing Mist with Eucalyptol & Menthol
Reason Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
Class III · Low risk Terminated
4 way Nasal Decongestant Menthol Nasal Spray
Reason Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
Class III · Low risk Terminated
4 way Nasal Decongestant Fast Acting Nasal Spray
Reason Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
Class III · Low risk Terminated
Nupercainal
Reason Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
Class III · Low risk Terminated
Myoflex
Reason Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
Class III · Low risk Terminated
Voltaren 1% Gel
Reason Labeling: Incorrect or Missing Lot and/or Expiration Date; This recall is being initiated because the lot number and expiration date on the tube may not be legible.
Class III · Low risk Terminated
Fenofibric Acid
Reason Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated." The labeling for the recalled lots
Class III · Low risk Terminated
Fenofibric Acid
Reason Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated." The labeling for the recalled lots
Class III · Low risk Terminated
Fibricor
Reason Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated." The labeling for the recalled lots
Class III · Low risk Terminated
Lisinopril Tablets
Reason Tablets/Capsules Imprinted With Wrong ID: Pharmaceuticals are imprinted with an incorrect identifier code on the embossed tablets..
Class III · Low risk Terminated
Ethambutol Hydrochloride Tablets USP
Reason Failed Impurities/Degradation Specifications: This product is being recalled due to an out of specification result for an impurity.
Class III · Low risk Terminated
Voltaren Gel
Reason Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
Class III · Low risk Terminated
Lamisil AT Cream
Reason Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
Class III · Low risk Terminated
Novartis Lamisil AT Cream for Jock Itch
Reason Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
Class III · Low risk Terminated
Target Up & Up
Reason Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot..
Class III · Low risk Terminated
Novartis Lamisil AT Cream
Reason Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
Class III · Low risk Terminated
PE Daytime Cold/Flu LiqGel
Reason Subpotent; 12 month time point for the active ingredient Phenylephrine HCl.
Class III · Low risk Terminated
Femhrt
Reason Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.
Class III · Low risk Terminated
Jevantique
Reason Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.
Class III · Low risk Terminated
Femhrt
Reason Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.
Class III · Low risk Terminated
Dextroamphetamine Saccharate
Reason Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceeding dissolution specifications. All other test specifications were met.
Class III · Low risk Terminated
Montelukast Sodium Tablets
Reason Chemical Contamination: The recall has been initiated based on multiple complaints received from pharmacists and consumers reporting that they detected an off-odor, described as moldy, musty or fishy in nature which has been identified as trace levels of Tribromoanisole (TBA) and Trichloroanisole (TCA).