Class III · Low risk
Chlorhexidine Gluconate Oral Rinse
Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
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
Lupin Cefdinir powder for Oral Suspension USP
Superpotent Drug
Class III · Low risk
Fabior (tazarotene)
Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point.
Class III · Low risk
Psoriasin Daytime Relief Cream with Vitamin D & Oatmeal
Subpotent Drug: The product has failed to maintain its label claim of coal tar throughout its labeled 24-month expiry period.
Class III · Low risk
Flucanazole Injection
Superpotent and Failed Stability Specifications; out of specification results for assay and water vapor permeability
Class III · Low risk
Methylphenidate Hydrochloride Extended-release Tablets
Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to contain 1 27 mg Methylphenidate HCL ER Tablet.
Class II · Moderate risk
PVP Scrub Solution
Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry.
Class III · Low risk
Cystaran (cysteamine ophthalmic solution)
Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride.
Class III · Low risk
Megestrol Acetate Oral Suspension
Subpotent Drug: Out of specification for assay (stability testing)
Class III · Low risk
Life Brand Clear Action Acne Treatment Concealer Stick
Superpotent drug: failed assay throughout the stick after 6 months stability.
Class III · Low risk
Cefuroxime
Subpotent Drug: The product is sub-potent prior to its 90-day beyond use date.
Class I · High risk
Class III · Low risk
Clobetasol Propionate Cream USP
Failed Content Uniformity Specifications
Class III · Low risk
Methylphenidate Hydrochloride Extended-release Tablets
Subpotent Drug
Class III · Low risk
Methylphenidate Hydrochloride Extended-release Tablets
Subpotent Drug
Class II · Moderate risk
Viokace (pancrelipase)
Subpotent Drug: One lot of Viokace is being recalled since product stability testing results did not meet the specifications for enzyme profile.
Class III · Low risk
Fluconazole Injection
Superpotent
Class III · Low risk
Ciprofloxacin in Dextrose
Superpotent
Class II · Moderate risk
ePHEDrine Sulfate In 0.9% Sodium Chloride
Subpotent Drug
Class II · Moderate risk
Zoloft (sertraline HCl)
SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
Class I · High risk
diphenoxylate hydrochloride and atropine sulfate tablets
SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
Class II · Moderate risk
Hydromorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride Injection 1 mL
Superpotent drug: out of specification result for potency
Class II · Moderate risk
Betadine Solution Swabstick Povidone-Iodine Solution USP
Subpotent Drug: The laminate used to make the pouches was reversed such that the aluminum layer was in contact with the product causing an exothermic reaction between the free iodine and the aluminum.
Class II · Moderate risk
Phenylephrine HCL 100 mcg per mL
Superpotent Drug
Class III · Low risk
Esterified Estrogens & Methyltestosterone Tablets
Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
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