Class II · Moderate risk
Losartan Potassium USP
CGMP deviation: Product found to contain trace amounts of NMBA
FDA Drug Recalls
1,563 recalls, newest first
Class II · Moderate risk
Little Remedies New Baby Essentials Kit. Each kit contains 1 each…
Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items contained within the kit.
Class III · Low risk
Mirapex (pramipexole dihydrochloride)
Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing.
Class II · Moderate risk
Losartan Potassium Tablets
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified.
Class II · Moderate risk
Valsartan Tablets USP 160 mg
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Class II · Moderate risk
Docetaxel Injection USP
Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterility assurance.
Class I · High risk
LEOPARD Miracle Honey packaged in a wooden box
Marketed Without An Approved NDA/ANDA: product tainted with undeclared sildenafil, an FDA approved drug for the treatment of male erectile dysfunction. The presence of sildenafil in Leopard Miracle Honey renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Class II · Moderate risk
Losartan Potassium and Hydrochlorothiazide Tablets
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
Class II · Moderate risk
Losartan Potassium and Hydrochlorothiazide Tablets
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
Class II · Moderate risk
Losartan Potassium Tablets USP 50 mg 50 Tablets
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
Class II · Moderate risk
Losartan Potassium 100 mg Tablets # 30 Losartan potassium tablets USP
CGMP Deviations:Traces amounts of N-Nitroso N-Methyl 4- amino butyric acid (NMBA) impurity found in Active Pharmaceutical Ingredient (API).
Class III · Low risk
ATHLETICARE Anti-Bacterial Hand Soap AC 550
Does Not Meet Monograph: product contains, triclosan, an ingredient that can no longer be contained in over-the-counter consumer antiseptic/antibacterial wash products.
Class II · Moderate risk
Aspirin and Extended-release Dipyridamole Capsules
Failed Impurities/Degradation Specifications; out of specification result for an unknown impurity in stability samples.
Class II · Moderate risk
Losartan Potassium Tablets
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected.
Class III · Low risk
Oxybutynin Chloride Extended-Release Tablets USP 10 mg
Failed Dissolution Specifications
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.