Class I · High risk
DDAVP Nasal Spray
Superpotent Drug
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 III · Low risk
Clobetasol Propionate Cream USP
Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
Class II · Moderate risk
Hydrocortisone butyrate Cream
SUBPOTENT DRUG
Class I · High risk
blumen ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT
Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.
Class I · High risk
blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70%…
Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.
Class I · High risk
blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL
Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.
Class III · Low risk
Skin Medica Acne System
SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.
Class III · Low risk
Skin Medica Acne Treatment Lotion
SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.
Class II · Moderate risk
Cefdinir for Oral Suspension USP
Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.
Class II · Moderate risk
Heparin Sodium 5
Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
Class II · Moderate risk
Tropical Lip Moisturizer
Superpotent Drug: The beginning portion of the batch appears to be approximately 25% superpotent for active ingredient Meradimate.
Class II · Moderate risk
Koala Hand Sanitizer
Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.
Class II · Moderate risk
Koala Hand Sanitizer
Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.
Class II · Moderate risk
Koala Hand Sanitizer
Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.
Class II · Moderate risk
Nystatin Cream
Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
Class II · Moderate risk
Nystatin Cream
Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
Class I · High risk
Minoxidil/Biotin/Spironolactone 1.25/5/25 mg capsule
Super-potent Drug: This recall has been initiated due to the elevated presence of minoxidil and biotin.
Class II · Moderate risk
Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm
Superpotent Drug: Active Ingredient Octisalate found at 15% above label claim.
Class II · Moderate risk
Handese Advanced Instant Hand Sanitizer
Subpotent Drug: Product was found to be subpotent. Product also has high pH levels
Class II · Moderate risk
oxyTOCIN 30 Units/500 mL
Subpotent drug - Product did not contain drug.
Class I · High risk
NP Thyroid 90
Superpotent Drug.
Class I · High risk
NP Thyroid 60
Superpotent Drug.
Class I · High risk
NP Thyroid 30
Superpotent Drug.
Class II · Moderate risk
EcoLips Sport Lip Balm
Superpotent Drug: The active ingredient, avobenzone, is used at 5% which is higher than the allowable 3% in the sunscreen formula per FDA sunscreen regulations.
Class II · Moderate risk
Cefixime for Oral Suspension USP
Subpotent Drug: low out of specification (OOS) test result observed in long term stability study.
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