Class II · Moderate risk
All estriol Products
Lack of Processing Controls
FDA Drug Recalls
1,103 recalls, newest first
Class II · Moderate risk
All testosterone Products
Lack of Processing Controls
Class I · High risk
Cap-Biotin 100 Mg
Labeling: Label Mix-Up: Products labeled Biotin 100 mg found to contain 4-aminopyridine
Class II · Moderate risk
All 4-aminopyridine Products
Lack of Processing Controls
Class III · Low risk
Venlafaxine 75 mg Tablet
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
5% Dextrose Injection USP
Non-Sterility: fungal contamination due to leaking containers.
Class III · Low risk
Escitalopram Tablets USP 20 mg
Labeling: Incorrect or Missing Lot and/or Expiration Date
Class III · Low risk
Zemplar (paricalcitol)
Failed Content Uniformity Specifications
Class III · Low risk
Simvastatin Tablets
Subpotent Drug
Class II · Moderate risk
PerioRx (chlorhexidine gluconate)
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Class II · Moderate risk
Chlorhexidine gluconate
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Class II · Moderate risk
ORIS (chlorhexidine gluconate)
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Class II · Moderate risk
Renovo Patch
Marketed Without An Approved NDA/ANDA: product is an unapproved drug and additionally 3 lots were found to be subpotent.
Class III · Low risk
Fenofibrate Capsules
Labeling: Incorrect or Missing Lot and/or Exp. Date
Class III · Low risk
Fenofibrate Capsules
Labeling: Incorrect or Missing Lot and/or Exp. Date
Class III · Low risk
Ciprofloxacin Ophthalmic Solution
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
Dextroamphetamine Sulfate Tablets USP
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Dextroamphetamine Sulfate Tablets USP
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL)
Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.
Class II · Moderate risk
Formula 0 (PGE 20 mcg/mL)
Lack of Assurance of Sterility: incomplete or missing data regarding production.
Class II · Moderate risk
Formula 3 (Papaverine 20 mg, Phentolamine 3 mg, Atropine 0.2 mg, PGE 20 mcg/mL)
Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.
Class II · Moderate risk
Formula 1
Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.
Class II · Moderate risk
Formula 9
Lack of Assurance of Sterility: incomplete or missing data regarding production.
Class II · Moderate risk
Formula 4 (Papaverine 18 mg, Phentolamine 2 mg, Atropine 0.2 mg/mL)
Lack of Assurance of Sterility: incomplete or missing data regarding production.
Class II · Moderate risk
Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL)
Superpotent Drug: one ingredient was found to be above assay specification.