Class II · Moderate risk Terminated
All testosterone Products
Reason Lack of Processing Controls
FDA Drug Recalls
14,801 recalls, newest first
Class I · High risk Terminated
Cap-Biotin 100 Mg
Reason Labeling: Label Mix-Up: Products labeled Biotin 100 mg found to contain 4-aminopyridine
Class II · Moderate risk Terminated
All 4-aminopyridine Products
Reason Lack of Processing Controls
Class III · Low risk Terminated
Venlafaxine 75 mg Tablet
Reason Labeling: Label Mix-Up: Bryant Ranch received Tevas venlafaxine hydrochloride extended-release tablets for repackaging, but labeled it incorrectly as the immediate release formulation.
Class I · High risk Terminated
5% Dextrose Injection USP
Reason Non-Sterility: fungal contamination due to leaking containers.
Class III · Low risk Terminated
Escitalopram Tablets USP 20 mg
Reason Labeling: Incorrect or Missing Lot and/or Expiration Date
Class III · Low risk Terminated
Zemplar
Reason Failed Content Uniformity Specifications
Class III · Low risk Terminated
Simvastatin Tablets
Reason Subpotent Drug
Class II · Moderate risk Terminated
PerioRx
Reason Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Class II · Moderate risk Terminated
Chlorhexidine gluconate
Reason Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Class II · Moderate risk Terminated
Oris
Reason Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Class II · Moderate risk Terminated
Renovo Patch
Reason Marketed Without An Approved NDA/ANDA: product is an unapproved drug and additionally 3 lots were found to be subpotent.
Class III · Low risk Terminated
Fenofibrate Capsules
Reason Labeling: Incorrect or Missing Lot and/or Exp. Date
Class III · Low risk Terminated
Fenofibrate Capsules
Reason Labeling: Incorrect or Missing Lot and/or Exp. Date
Class III · Low risk Terminated
Ciprofloxacin Ophthalmic Solution
Reason Failed Impurities/Degradation Specifications: Firm voluntarily recalled products due to out-of-specification results for an unknown impurity at or near the expiration (24-month).
Class II · Moderate risk Terminated
Dextroamphetamine Sulfate Tablets USP
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Dextroamphetamine Sulfate Tablets USP
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Formula 2
Reason Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.
Class II · Moderate risk Terminated
Formula 0
Reason Lack of Assurance of Sterility: incomplete or missing data regarding production.
Class II · Moderate risk Terminated
Formula 3
Reason Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.
Class II · Moderate risk Terminated
Formula 1
Reason Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.
Class II · Moderate risk Terminated
Formula 9
Reason Lack of Assurance of Sterility: incomplete or missing data regarding production.
Class II · Moderate risk Terminated
Formula 4
Reason Lack of Assurance of Sterility: incomplete or missing data regarding production.
Class II · Moderate risk Terminated
Formula 2
Reason Superpotent Drug: one ingredient was found to be above assay specification.
Class III · Low risk Terminated
Ceftriaxone Sodium
Reason CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications.