Class III · Low risk
Panadol (acetaminophen)
Failed Dissolution Specifications
Class III drug recalls - low risk
Class III means the product is unlikely to cause harm but violates FDA labeling or manufacturing rules. These are the recalls you rarely hear about; pharmacies usually just swap the affected lot.
1,716 recalls, newest first.
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.
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium tablets
Subpotent drug
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium tablets
Subpotent drug
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium tablets
Subpotent drug
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium tablets
Subpotent drug
Class III · Low risk
Loratadine Orally Disintegrating Tablets USP
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III · Low risk
Levalbuterol Inhalation Solution
Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
Class III · Low risk
IC-GREEN (indocyanine green for injection, USP)
Subpotent Drug: Low out-of-specification potency result of the drug product.
Class III · Low risk
Chlordiazepoxide HCl/Clidinium Bromide capsules
Failed Impurities/Degradation Specifications
Class III · Low risk
Librax (5 mg chlordiazepoxide HCl and 2.5 mg clidinium bromide)
Failed Impurities/Degradation Specifications