Class III · Low risk
Lisinopril Tablets USP
Labeling: Incorrect or Missing Package Insert
FDA Drug Recalls
362 recalls · Class III, newest first
Class III · Low risk
Lodrane D (Brompheniramine maleate 4 mg and Pseudoephedrine HCl 60 mg)
Labeling: Not Elsewhere Classified: correctly labeled bottles were packaged in cartons that were mislabeled with an incorrect active ingredient, phenylephrine rather than pseudoephedrine, on the carton face and carton top.
Class III · Low risk
Doxycycline
Labeling: Incorrect Or Missing Lot and/or Exp Date: Some expiries and lot numbers are missing.
Class III · Low risk
Hectorol (doxercalciferol injection)
Labeling: Wrong barcode. An incorrect bar code was noted on the vial label of Hectorol 2 mcg/1mL vial.
Class III · Low risk
Acetaminophen & Codeine Phosphate Tablets
Labeling: Not elsewhere classified - count on the label was incorrect.
Class III · Low risk
SKY Aspirin Chewable Tablets
Labeling: Label mix-up -outer carton incorrectly labeled as aspirin chewable tablets.
Class III · Low risk
Fenofibrate Capsules
Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk
Fenofibrate Capsules
Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk
Venlafaxine 75 mg Tablet
Labeling: Label Mix-Up: Bryant Ranch received Tevas venlafaxine hydrochloride extended-release tablets for repackaging, but labeled it incorrectly as the immediate release formulation.
Class III · Low risk
Escitalopram Tablets USP 20 mg
Labeling: Incorrect or Missing Lot and/or Expiration Date
Class III · Low risk
Fenofibrate Capsules
Labeling: Incorrect or Missing Lot and/or Exp. Date
Class III · Low risk
Fenofibrate Capsules
Labeling: Incorrect or Missing Lot and/or Exp. Date
Class III · Low risk
Quelicin (Succinylcholine Chloride)
Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for the lot number and/or expiration date to be faded or missing from the primary label on the glass vial.
Class III · Low risk
Sodium Iodide I 131 Capsule
Labeling: Label Error on Declared Strength
Class III · Low risk
Minocycline Hydrochloride Capsules USP
Labeling: Incorrect or Missing Lot and/or Exp Date: the individual blisters are mislabeled with an incorrect lot number of 13560 rather than the correct lot number of 13650.
Class III · Low risk
Adult Robitussin PEAK COLD Cough & Chest Congestion DM Liquid 8 oz. Bottle
Labeling: Label Mix-Up
Class III · Low risk
Triamcinolone Diacetate Injectable Suspension
Labeling: Incorrect or Missing Lot and/or Exp Date: some vials may be mislabeled with an incorrect "Compounded" date, lot number, and "Do Not Use Beyond " date or BUD (Before Use Date) that may be longer than intended.
Class III · Low risk
Normosol-M and 5% Dextrose
Labeling: Incorrect or Missing Lot and/or Exp Date: Confirmed customer report of an incorrect expiration date printed on the primary container labeled "01AUG1017" rather than "01AUG2017".
Class III · Low risk
Tropicamide Ophthalmic Solution USP
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Class III · Low risk
Tropicamide Ophthalmic Solution USP
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Class III · Low risk
Cyclopentolate Hydrochloride Ophthalmic Solution USP
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Class III · Low risk
Virt-Nate Prenatal/Postnatal
Tablets/Capsules Imprinted with Wrong ID; product debossed with an incorrect punch. Bottles could contain tablets debossed with V259 (debossing for PreTab) instead of the correct punch, V264 (debossing for Virt-Nate).
Class III · Low risk
Life-Line DOCUSATE CALCIUM Sodium Free STOOL SOFTENER 240 mg each
Labeling: Label mix-up. Docusate Sodium 100mg Softgels were mislabeled as Docusate Calcium 240mg.
Class III · Low risk
Lumizyme (alglucosidase alpha)
Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk
NABUMETONE Tablets USP
Labeling: Not Elsewhere Classified: Lack of leaflets and approved labels on bottles.