Class II · Moderate risk Terminated
Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Ongoing
Peripheral Parenteral Nutrition
Reason Lack of Processing Controls; prescriptions were compounded in an ISO-5 area where it was identified that a daily cleaning step was not sufficiently documented.
Class II · Moderate risk Ongoing
Budesonide Inhalation Suspension
Reason Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Class II · Moderate risk Ongoing
Omeprazole Delayed-release Capsules
Reason Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class I · High risk Ongoing
Buffered Penicillin G Potassium for Injection
Reason Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit
Class I · High risk Ongoing
Cefazolin for Injection
Reason Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained Cefozalin
Class II · Moderate risk Terminated
clomiPRAMINE Hydrochloride Capsules USP 25 mg
Reason Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.
Class III · Low risk Ongoing
Pitavastatin Tablets
Reason Failed Impurity/Degradation Specifications
Class III · Low risk Ongoing
Pitavastatin Tablets
Reason Failed Impurity/Degradation Specifications
Class II · Moderate risk Ongoing
Metoprolol Succinate Extended-Release Tablets
Reason Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.
Class II · Moderate risk Ongoing
Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg
Reason Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets
Reason Subpotent Drug: Assay below the approved specification
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets
Reason Subpotent Drug: Assay below the approved specification
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets
Reason Subpotent Drug: Assay below the approved specification
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets
Reason Subpotent Drug: Assay below the approved specification
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets
Reason Subpotent Drug: Assay below the approved specification
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets
Reason Subpotent Drug: Assay below the approved specification
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets
Reason Subpotent Drug: Assay below the approved specification
Class II · Moderate risk Ongoing
Gabapentin Capsules
Reason Defective container; blister packaging inadequately sealed.
Class II · Moderate risk Ongoing
Gabapentin Capsules
Reason Defective container; blister packaging inadequately sealed.
Class III · Low risk Ongoing
Testosterone 200 mg Pellet packaged in 1mL amber vials
Reason Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.
Class II · Moderate risk Ongoing
Lisdexamfetamine Dimesylate Capsules
Reason Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH).
Class II · Moderate risk Ongoing
0.9% Sodium Chloride Injection USP
Reason Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
Class III · Low risk Ongoing
Pitavastatin Tablets
Reason Failed Impurities/Degradation Specifications.