Class III · Low risk Terminated
risperiDONE ORALLY DISINTEGRATING TABLETS
Reason Failed Impurities/Degradation Specifications: Out of specification for a known degradant.
FDA Drug Recalls
1,709 recalls · Class III, newest first
Class III · Low risk Terminated
NORepinephrine Bitartrate
Reason Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration
Class III · Low risk Terminated
NORepinephrine Bitartrate
Reason Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration
Class III · Low risk Terminated
Candesartan Cilexetil Tablets
Reason Failed Impurities/Degradation Specifications; 9 month stability timepoint
Class III · Low risk Terminated
Life-Line DOCUSATE CALCIUM Sodium Free STOOL SOFTENER 240 mg each
Reason Labeling: Label mix-up. Docusate Sodium 100mg Softgels were mislabeled as Docusate Calcium 240mg.
Class III · Low risk Terminated
Ranitidine Syrup
Reason Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result detected during routine stability testing.
Class III · Low risk Terminated
VP-CH-PNV PRENATAL/POSTNATAL Prescription Folic Acid-Containing…
Reason Defective Delivery System: Product may contain leaking capsules.
Class III · Low risk Terminated
Lindane Lotion
Reason Super-Potent Drug: Out of Specification Assay test results were reported for stability samples.
Class III · Low risk Terminated
Lumizyme
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk Terminated
Quinapril Tablets USP 5 mg
Reason Failed Impurities/Degradation Specifications; Impurity A
Class III · Low risk Terminated
Norpace CR
Reason Failed Dissolution Specification
Class III · Low risk Terminated
Meclizine Hydrochloride Tablets
Reason Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class III · Low risk Terminated
Meclizine Hydrochloride Tablets
Reason Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class III · Low risk Terminated
NABUMETONE Tablets USP
Reason Labeling: Not Elsewhere Classified: Lack of leaflets and approved labels on bottles.
Class III · Low risk Terminated
Prednisone 20 mg
Reason Labeling: Not elsewhere classified. NDC number is incorrect on the container.
Class III · Low risk Terminated
Paricalcitol Capsules
Reason Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.
Class III · Low risk Terminated
Paricalcitol Capsules
Reason Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.
Class III · Low risk Terminated
Paricalcitol Capsules
Reason Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.
Class III · Low risk Terminated
Meclizine Hydrochloride Tablets
Reason Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class III · Low risk Terminated
Magnesium Sulfate 7-Hydrate
Reason Failed Impurities/Degradation Specifications: Out of specifications results for impurities.
Class III · Low risk Terminated
Epsom Salt
Reason Failed Impurities/Degradation Specifications: Level of iron exceeds the limit set by the USP monograph for it (USP limit is NMT 0.5 ug/g (ppm)).
Class III · Low risk Terminated
Meclizine Hydrochloride Tablets USP
Reason Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class III · Low risk Terminated
Meclizine Hydrochloride Tablets
Reason Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class III · Low risk Terminated
Duloxetine Delayed-release Capsules
Reason Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle
Class III · Low risk Terminated
Ranitidine Syrup
Reason Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben.