Class II · Moderate risk
Levothyroxine Sodium Tablets USP
Superpotent Drug and Subpotent Drug: potency failures obtained
Wrong potency or content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk.
992 FDA drug recalls with this cause, newest first.
These recalls cover sub-potent or super-potent products, or a failed content-uniformity test - meaning some pills in the same batch held noticeably different amounts of active ingredient than others. Either way it is a direct dosing risk: too little to work, or too much and harmful. Thyroid hormones and compounded injectables are the classic examples, because their dose window is narrow.
Class II · Moderate risk
Levothyroxine Sodium Tablets USP
Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk
Levothyroxine Sodium Tablets USP
Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk
Levothyroxine Sodium Tablets USP
Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk
Levothyroxine Sodium Tablets USP
Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk
Levothyroxine Sodium Tablets USP
Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk
Levothyroxine Sodium Tablets USP
Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent drug
Class II · Moderate risk
Lisdexamfetamine Dimesylate Capsules
Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.
Class II · Moderate risk
Chlorpheniramine Maleate 4 mg tablets
Superpotent Drug: Stability failure for assay at 6 months test time-point.
Class II · Moderate risk
Class III · Low risk
Triamcinolone Acetonide Cream USP
Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing.
Class II · Moderate risk
Mupirocin Ointment
Subpotent Drug
Class II · Moderate risk
Cefixime for Oral Suspension USP
Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
Class II · Moderate risk
Testosterone Gel
Superpotent Drug
Class II · Moderate risk
Lidocaine HCL Injection
Subpotent Drug: reduced efficacy for epinephrine
Class III · Low risk
Hemp Bombs CBD Pain Freeze
Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Class III · Low risk
Hemp Bombs CBD Pain Freeze
Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Class III · Low risk
Nature's Script CBD Cryotherapy Pain Relief Roll on
Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Class III · Low risk
Hemp Bombs CBD Pain Freeze
Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Class III · Low risk
Dodex Injectable
Subpotent drug: out of specification results
Class II · Moderate risk
Amoxicillin and Clavulanate Potassium Tablets USP
Subpotent Drug
Class II · Moderate risk
Cefixime for Oral Suspension USP 200 mg/5 mL
Failed Content Uniformity Specifications
Class II · Moderate risk
Vasopressin Injection
Subpotent product in addition to having out-of-specification results for impurities.
Class III · Low risk
Sodium Sulfacetamide 10% - Sulfur 5% Cleanser
Subpotent drug
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