Class III · Low risk Terminated
Absorica
Reason Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Terminated
Medline Remedy Essential Barrier Skin Protectant Ointment
Reason GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Class II · Moderate risk Terminated
Hydrocortisone Cream 1% MS Anti itch Cream with Intensive Healing 2 oz tubes
Reason GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Class II · Moderate risk Terminated
Soothe & Cool Protect Moisture Guard Skin Protectant
Reason GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Class II · Moderate risk Terminated
Levoxyl
Reason Superpotent Drug.
Class II · Moderate risk Terminated
Fentanyl Citrate 2 mcg per mL
Reason Sub-potent
Class II · Moderate risk Terminated
Fentanyl Citrate 2 mcg per mL
Reason Sub-potent
Class II · Moderate risk Ongoing
Valsartan and Hydrochlorothiazide Tablets
Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Class II · Moderate risk Ongoing
Valsartan and Hydrochlorothiazide Tablets
Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Class II · Moderate risk Ongoing
Valsartan and Hydrochlorothiazide Tablets
Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Class II · Moderate risk Ongoing
Valsartan and Hydrochlorothiazide Tablets
Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Class II · Moderate risk Ongoing
Valsartan and Hydrochlorothiazide Tablets
Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Class II · Moderate risk Ongoing
Valsartan Tablets
Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Class II · Moderate risk Ongoing
Valsartan Tablets
Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Class II · Moderate risk Ongoing
Valsartan Tablets
Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Class II · Moderate risk Ongoing
Valsartan Tablets
Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Class II · Moderate risk Ongoing
Amlodipine and Valsartan Tablets
Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Class II · Moderate risk Ongoing
Amlodipine and Valsartan Tablets
Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Class II · Moderate risk Ongoing
Amlodipine and Valsartan Tablets
Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Class II · Moderate risk Ongoing
Amlodipine and Valsartan Tablets
Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Class II · Moderate risk Terminated
Estradiol Tablets
Reason Presence of foreign tablet/capsule: A single foreign tablet was found in pharmacy dispensed bottle of 30 Estradiol 2 mg tablets.
Class III · Low risk Terminated
NYSTATIN Oral Suspension
Reason Failed Impurities/Degradation Specifications:Out of specification for impurities.
Class III · Low risk Terminated
Amlodipine and Olmesartan Medoxomil Tablets
Reason 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 Terminated
Phenylephrine HCl
Reason 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 Terminated
Aprepitant Capsules
Reason Shortfill: Aprepitant capsules 40 mg is being recalled due to customer reports of missing capsule in the blister pack.