Class III · Low risk
Enoxaparin Sodium
Labeling: Label Error on Declared Strength. A single syringe labeled as 150 mg/1.0 mL was found packaged in a blister labeled as 120 mg/mL
FDA Drug Recalls
33 recalls · Class III, newest first
Class III · Low risk
Doan's Pain Relieving Cream with 4% Lidocaine Plus Menthol
Labeling: Incorrect or Missing Lot and/or Exp Date; lot number on the secondary packaging doesnt match the lot number printed on the bottle
Class III · Low risk
Clofarabine injection
Labeling: Incorrect or Missing Package Insert: authorized generic product was packaged with the incorrect insert for the brand name product Clolar (clofarabine) injection.
Class III · Low risk
Clolar (clofarabine)
Labeling: Incorrect or Missing Package Insert.
Class III · Low risk
HYDROmorphone HCl in 0.9% Sodium Chloride Injection
Labeling: Incorrect or Missing Lot and/or Exp. Date
Class III · Low risk
morphine Sulfate in 0.9% Sodium Chloride Injection 1 mL Total Volume 2 mg per mL
Labeling: Incorrect or Missing Lot and/or Exp. Date
Class III · Low risk
morphine Sulfate in 0.9% Sodium Chloride Injection 2 mL Total Volume 1 mg per mL
Labeling: Incorrect or Missing Lot and/or Exp. Date
Class III · Low risk
Ampicillin for Injection
Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap pack are missing labels.
Class III · Low risk
Mobic (meloxicam)
Labeling: Incorrect or missing package insert. One lot of Mobic Tablets is packaged with an incorrect insert.
Class III · Low risk
Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL
Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance
Class III · Low risk
Obagi-C Rx System C-Therapy Night Cream
Labeling: Incorrect or Missing Package Insert - Obagi-C Rx System C-Therapy Night Cream is being recalled due to incomplete packaging/labeling. The bottle is missing the product insert and outer carton which contain the complete instruction for use and safety information.
Class III · Low risk
Walgreens Daytime and Nighttime Cold & Flu
Labeling: Label Mix-Up - This product is being recalled due to an incorrect product sleeve on the product twin pack. The incorrect product sleeve is for Day-Night Cold and Flu whereas the batch contains Day-Night Cough Liquid.
Class III · Low risk
Zinc Oxide Paste 25%
Labeling: Error on Declared Strength: Error is due to an incorrect value in the Drug Facts Panel. The correct strength is displayed on the primary container.
Class III · Low risk
Ciclopirox Olamine Cream USP
Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.
Class III · Low risk
A+D Diaper Rash Cream with Dimethicone 1% and Zinc Oxide 10%
Labeling: Incorrect/Undeclared Excipients: Firm is recalling A+D Diaper Rash Cream due to a labeling claim issue.
Class III · Low risk
Potassium PHOSphate added to 0.9% Sodium Chloride
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class III · Low risk
Potassium PHOSphate added to 0.9% Sodium Chloride
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class III · Low risk
Potassium PHOSphate added to 0.9% Sodium Chloride
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class III · Low risk
Potassium PHOSphate added to 0.9% Sodium Chloride
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class III · Low risk
Potassium PHOSphate added to 0.9% Sodium Chloride
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class III · Low risk
Potassium CHLORide added to 0.9% Sodium Chloride
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class III · Low risk
Potassium CHLORide added to 0.9% Sodium Chloride
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class III · Low risk
Bupivacaine HCl 0.25% 400 mL Total Volume in an ON-Q Pump in 0.9%…
Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk
Bupivacaine HCl 0.25% 270 mL Total Volume in an ON-Q Pump in 0.9%…
Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk
Ropivacaine HCl 0.2% 550 mL Total Volume in an AutoFuser Pump in…
Labeling: Incorrect or Missing Lot and/or Exp Date