Class III · Low risk
Imipramine HCl Tablets
Chemical Contamination; benzophenone leached from the product label varnish
FDA Drug Recalls
1,525 recalls · Class III, newest first
Class III · Low risk
Felodipine Extended-Release Tablets
Chemical Contamination; benzophenone leached from the product label varnish
Class III · Low risk
Felodipine Extended-Release Tablets
Chemical Contamination; benzophenone leached from the product label varnish
Class III · Low risk
Felodipine Extended-Release Tablets
Chemical Contamination; benzophenone leached from the product label varnish
Class III · Low risk
Phentermine Hydrochloride Capsules
Failed Impurities/Degradation Specifications: out-of-specification results for individual unknown and total impurity at the 12th month room temperature stability test station
Class III · Low risk
Mometasone Furoate Ointment USP
Subpotent drug
Class III · Low risk
Intermezzo
Failed dissolution specifications
Class III · Low risk
Maximum Strength Analgesic Thera-Gesic Pain Relieving Creme…
Subpotent Drug: menthol and methyl salicylate below specification
Class III · Low risk
Cvs Sugar Free Black Cherry Cough Drops
Presence of Foreign Tablets/Capsules: Presence of comingled Sugar Free Honey Lemon cough drops.
Class III · Low risk
Panadol (acetaminophen)
Failed Dissolution Specifications
Class III · Low risk
HydrOXYzine Hydrochloride Tablets
Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable
Class III · Low risk
Metoclopramide Oral Solution
Defective Container: Lids on unit dose cups are not fully qualified.
Class III · Low risk
Desmopressin Acetate Tablets
Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side.
Class III · Low risk
Desmopressin Acetate Tablets
Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side.
Class III · Low risk
Cortisol-Mc
Failed Content Uniformity Specifications: Failed Uniformity of Dosage Units specifications.
Class III · Low risk
Disulfiram tablets
Failed Dissolution Specifications: During routine stability testing at the 12 month time point, one product lot was found to be out of specification for dissolution.
Class III · Low risk
Carb-O-Philic 40 Cream
CGMP Deviation: Poor container closure of the bulk storage container
Class III · Low risk
Dr Blue Pain Relieving Gel
Superpotent Drug: Product may not be uniformly blended resulting in non-uniform distribution of the active ingredient menthol.
Class III · Low risk
Lutera (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets USP)
Labeling: Incorrect or Missing Package Insert; Product is being recalled because the birth control packs were distributed with out-dated package inserts.
Class III · Low risk
E-Z-CAT Dry Barium Sulfate for Suspension
Failed stability specifications:This recall has been initiated due to out of specification results for viscosity.
Class III · Low risk
Foradil Aerolizer
Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.
Class III · Low risk
Foradil Aerolizer
Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.
Class III · Low risk
Magnesium Sulfate Injection
Failed pH Specifications: 12 month stability testing
Class III · Low risk
Fentanyl Citrate Inj.
Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).
Class III · Low risk
QVAR (beclomethasone dipropionate HFA 40 mcg)
Failed Impurities/Degradation Specifications: out of specification test results for an impurity during stability testing.