Class III · Low risk
Levofloxacin Injection in 5% Dextrose
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
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
Levofloxacin Injection in 5% Dextrose
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Class III · Low risk
Fluconazole Injection
Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay.
Class III · Low risk
Fluconazole Injection
Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodium chloride and elevated water vapor.
Class III · Low risk
Triamterene and Hydrochlorothiazide Tablets
Subpotent Drug
Class II · Moderate risk
Buffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic Use
Subpotent Drug: Stability data does not support the current expiration dating of 55 days after compounding.
Class II · Moderate risk
Nitrofurantoin Oral Suspension USP
Subpotent Drug and Failed Content Uniformity.
Class II · Moderate risk
fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL
Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated on the label.
Class III · Low risk
Rocaltrol (calcitriol)
Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
Class III · Low risk
Calcitriol Oral Solution
Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
Class II · Moderate risk
Irinotecan Hydrochloride Injection
Superpotent Drug: High out of specification assay value results for potency.
Class II · Moderate risk
Irinotecan Hydrochloride Injection
Superpotent Drug: High out of specification assay value results for potency.
Class III · Low risk
Maxzide-25
Superpotent Drug: Composite assay results obtained during routine stability testing were slightly above specification.
Class II · Moderate risk
HYDROmorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride
Superpotent and Subpotent
Class I · High risk
Piperacillin and Tazobactam for Injection
Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
Class I · High risk
Piperacillin and Tazobactam for Injection
Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
Class III · Low risk
Zoma Shampoo
Subpotent
Class III · Low risk
T Shampoo For Hair and Body
Subpotent
Class II · Moderate risk
Docetaxel injection concentrate
Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have been distributed.
Class II · Moderate risk
Fluocinolone Acetonide Topical Oil
Subpotent Drug
Class II · Moderate risk
Fluocinolone Acetonide Topical Oil
Subpotent Drug
Class II · Moderate risk
Fluocinolone Acetonide Topical Oil
Subpotent Drug
Class III · Low risk
Cystaran (cysteamine ophthalmic solution)
Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride.
Class III · Low risk
24-HOUR Oral Care q4 Kit with Ballard* Technology
Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Class III · Low risk
24-HOUR Oral Care q2 Kit with Ballard* Technology
Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.