Class II · Moderate risk
All fluocinonide Products
Lack of Processing Controls
FDA Drug Recalls
966 recalls · Class II, newest first
Class II · Moderate risk
All Germall
Lack of Processing Controls
Class II · Moderate risk
All betamethasone diproprionate Products
Lack of Processing Controls
Class II · Moderate risk
All monobenzone Products
Lack of Processing Controls
Class II · Moderate risk
All carbomer Products
Lack of Processing Controls
Class II · Moderate risk
All progesterone Products
Lack of Processing Controls
Class II · Moderate risk
All Peterson Cream Products
Lack of Processing Controls
Class II · Moderate risk
All TRIE Products
Lack of Processing Controls
Class II · Moderate risk
All estriol Products
Lack of Processing Controls
Class II · Moderate risk
All testosterone Products
Lack of Processing Controls
Class II · Moderate risk
All 4-aminopyridine Products
Lack of Processing Controls
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 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.
Class II · Moderate risk
Potassium Chloride Injection 20 mEq
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.