Class III · Low risk
Oxybutynin Chloride Extended-Release Tablets USP 10 mg
Failed Dissolution Specifications
FDA drug recalls in 2019
Every FDA drug recall initiated in 2019, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,788 recalls, newest first.
Class II · Moderate risk
Losartan Potassium / Hydrochlorothiazide Tablets
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Class II · Moderate risk
Losartan Potassium / Hydrochlorothiazide Tablets
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Class II · Moderate risk
Losartan Potassium / Hydrochlorothiazide Tablets
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Class II · Moderate risk
Losartan Potassium Tablets
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Class II · Moderate risk
Losartan Potassium Tablets
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Class II · Moderate risk
Losartan Potassium Tablets
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Class II · Moderate risk
Losartan Potassium Tablets USP
CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
Class II · Moderate risk
Losartan Potassium Tablets USP
CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
Class II · Moderate risk
Losartan Potassium Tablets USP
CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
Class III · Low risk
BuPROPion Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications; 9-monthstability timepoint
Class III · Low risk
Moxifloxacin Ophthalmic Solution USP
Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities.
Class II · Moderate risk
Telmisartan and Hyrdochlorothiazide Tablets 80 mg/25 mg
Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.
Class II · Moderate risk
Telmisartan and Hyrdochlorothiazide Tablets
Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.
Class II · Moderate risk
Telmisartan and Hyrdochlorothiazide Tablets 40mg/12.5 mg
Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.
Class II · Moderate risk
Tamsulosin Hydrochloride Capsules
Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed during stability testing.
Class I · High risk
Golean DETOX capsules
Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain undeclared sibutramine and phenolphthalein. Sibutramine is an appetite suppressant that was withdrawn from the US market due to safety concerns. Phenolphthalein was once an ingredient used in over-the-counter laxatives, but because of concerns of carcinogenicity is not currently approved for marketing in the US. The presence of sibutramine and phenolphthalein in this product renders it an unapproved drug for which the safety and efficacy has not been established and, therefore, subject to recall.
Class II · Moderate risk
Gentamicin Sulfate Ophthalmic Solution
Failed Impurities/Degradation Specifications: High Out-of-Specification (OOS) results for Individual and Total Impurities that have been identified at the 18 months stability testing time point.
Class II · Moderate risk
Papaverine-Phentolamine-Pge1 17.44-0.64mg-5.8mcg/Ml* Injectable
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
Papaverine-Phentolamine-Pge1 17.44-0.58mg-5.8mcg/Ml* Injectable
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
Papaverine-Phentolamine-Pge1 15-0.25mg-6mcg/Ml Injectable
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
Papaverine-Phentolamine-Pge1 30-1 Mg-20 Mcg/Ml* Injectable
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
Papaverine-Phentolamine-Pge1 9-1 Mg-10 Mcg/Ml* Injectable
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
Papaverine-Phentolamine-Pge1 22.5-0.8mg-8.3mcg/Ml Injectable
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
Papaverine-Phentolamine-Pge1 17.64-0.58mg-5.88mcg/Ml* Injectable
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.