Class I · High risk
Lamotrigine Orally Disintegrating Tablets
Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs
FDA Drug Recalls
60 recalls, newest first
Class III · Low risk
Amoxicillin For Oral Suspension
Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed.
Class III · Low risk
Mozobil (plerixafor injection)
Labeling: Incorrect or Missing Lot and/or Exp. Date
Class III · Low risk
Mucinex Sinus-Max Day Night
Labeling: Label Error on Declared Strength; label on outer carton incorrectly states Diphenhydramine 25 mg instead of 12.5 mg. Also, quantity is incorrectly stated as 30 daytime and 30 nighttime instead of 36 daytime and 24 nighttime.
Class III · Low risk
Methylprednisolone Tablets
Labeling: Incorrect or Missing Lot and/or Exp Date: incorrect expiration date of 02/0218 is printed on the container label instead of the correct expiration date of 02/2018.
Class III · Low risk
Seconal Sodium
Labeling: Incorrect or Missing Package Insert: Package insert is missing warning regarding anaphylaxis.
Class III · Low risk
Irbesartan and Hydrochlorothiazide Tablets
Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on the case label, the correct lot number, 327B16002 appears on the immediate container.
Class III · Low risk
Lisinopril Tablets USP
Labeling: Incorrect or Missing Package Insert
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 II · Moderate risk
Potassium CHLORide added to 5% Dextrose Injection
Labeling: Not Elsewhere Classified: Potassium Chloride was printed on Potassium Phosphate label stock thereby having both names on the label of a 250 mL bag of Potassium Chloride.
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 I · High risk
PHENYLephrine 1 mg/10 mL
Labeling: Label Error on Declared Strength. Product has correct label on the syringe and the case but some units are incorrectly labeled as .4 mg/10 mL (40 mcg/ml) on the light protective overwrap of each syringe.
Class I · High risk
Cap-Biotin 100 Mg
Labeling: Label Mix-Up: Products labeled Biotin 100 mg found to contain 4-aminopyridine
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.