Class III · Low risk
Formula F9
Sub Potent
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
NAD+ Nicotinamide Adenine Dinucleotide
Product found to be Sub Potent or Exceeded reconstitution time
Class II · Moderate risk
Class III · Low risk
Nandrolone Decanoate
Subpotent Drug
Class III · Low risk
Nandrolone Decanoate
Subpotent Drug
Class III · Low risk
Nandrolone Decanoate
Subpotent Drug
Class III · Low risk
Nandrolone Decanoate
Subpotent Drug
Class III · Low risk
Nandrolone Decanoate
Subpotent Drug
Class III · Low risk
Clotrimazole and Betamethasone Dipropionate Cream USP
Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample
Class III · Low risk
Sapropterin Dihydrochloride Powder for Oral Solution
Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.
Class III · Low risk
Norepinephrine bitartrate 16 mg in 250 mL NaCl 0.9%
Subpotent drug
Class II · Moderate risk
Premium Nature Instant Hand Sanitizer
Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
Class II · Moderate risk
Premium Nature Instant Hand Sanitizer
Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
Class III · Low risk
Mucus Relief D
Subpotent drug
Class II · Moderate risk
Sufentanil Citrate Injection
Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.
Class II · Moderate risk
Pioglitazone Tablets USP
Superpotent and Failed Tablet/Capsule Specifications
Class II · Moderate risk
Penicillin V Potassium for Oral Solution
Subpotent
Class III · Low risk
CTx12 5000 Kit which contains 3 boxes of CariFree CTx4 GEl 5000…
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Class III · Low risk
CariFree sample boxes
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Class III · Low risk
CTx36 Kit
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Class III · Low risk
CTx26 Kit
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Class III · Low risk
CTx21 Kit
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Class III · Low risk
CTx7 Kit
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Class III · Low risk
CariFree CTx4 GEl 5000 1.1% Neutral Sodium Fluoride Mint
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Class III · Low risk
Telmisartan and Hydrochlorothiazide Tablets
Superpotent; Hydrochlorothiazide
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