Class II · Moderate risk
Estradiol Tablets
Presence of foreign tablet/capsule: A single foreign tablet was found in pharmacy dispensed bottle of 30 Estradiol 2 mg tablets.
FDA Drug Recalls
18,003 recalls, newest first
Class III · Low risk
NYSTATIN Oral Suspension
Failed Impurities/Degradation Specifications:Out of specification for impurities.
Class III · Low risk
Amlodipine and Olmesartan Medoxomil Tablets
Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets from this lot were a pink color instead of cream (peach).
Class I · High risk
Phenylephrine HCl
Labeling: Label Error on Declared Strength: Label incorrectly lists concentration as "10 mcg per mL" rather than the correct concentration of "100 mcg per mL".
Class III · Low risk
Aprepitant Capsules
Shortfill: Aprepitant capsules 40 mg is being recalled due to customer reports of missing capsule in the blister pack.
Class II · Moderate risk
Amlodipine
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class II · Moderate risk
Amlodipine
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class II · Moderate risk
Amlodipine
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class II · Moderate risk
Amlodipine
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class II · Moderate risk
Amlodipine and Valsartan Tablets 10 mg/320 mg
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class II · Moderate risk
Amlodipine and Valsartan Tablets 5 mg/320 mg
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class II · Moderate risk
Amlodipine and Valsartan Tablets 10 mg/160 mg
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class II · Moderate risk
Amlodipine and Valsartan Tablets 5 mg/160 mg
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class II · Moderate risk
Infants' Ibuprofen
Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Class II · Moderate risk
Infants' Ibuprofen
Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Class II · Moderate risk
infants* IBUPROFEN
Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Class III · Low risk
Norepinephrine 8 mg
Incorrect excipient: Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride
Class II · Moderate risk
Amlodipine and Valsartan Tablets
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Class II · Moderate risk
Valsartan and Hydrochlorothiazide Tablets
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Class II · Moderate risk
Valsartan Tablets
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Class II · Moderate risk
Valsartan Tablets
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Class II · Moderate risk
Valsartan Tablets
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Class II · Moderate risk
Valsartan Tablets
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Class II · Moderate risk
Amlodipine and Valsartan Tablets
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Class II · Moderate risk
Amlodipine and Valsartan Tablets
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.