Class II · Moderate risk
Omeprazole Delayed-release Capsules
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Ongoing drug recalls - open right now
Every FDA drug recall whose status is still Ongoing: the firm is still removing product from the market, or the FDA has not yet closed the file. Some were opened years ago and never formally terminated, so check the initiation date as well as the status.
2,760 recalls, newest first.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class I · High risk
Buffered Penicillin G Potassium for Injection
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
Cefazolin for Injection
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 III · Low risk
Pitavastatin Tablets
Failed Impurity/Degradation Specifications
Class III · Low risk
Pitavastatin Tablets
Failed Impurity/Degradation Specifications
Class II · Moderate risk
Metoprolol Succinate Extended-Release Tablets
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
Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg
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
Levothyroxine Sodium Tablets
Subpotent Drug: Assay below the approved specification
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug: Assay below the approved specification
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug: Assay below the approved specification
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug: Assay below the approved specification
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug: Assay below the approved specification
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug: Assay below the approved specification
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug: Assay below the approved specification
Class II · Moderate risk
Gabapentin Capsules
Defective container; blister packaging inadequately sealed.
Class II · Moderate risk
Gabapentin Capsules
Defective container; blister packaging inadequately sealed.
Class III · Low risk
Testosterone 200 mg Pellet packaged in 1mL amber vials
Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.
Class II · Moderate risk
Lisdexamfetamine Dimesylate Capsules
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
0.9% Sodium Chloride Injection USP
Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
Class III · Low risk
Pitavastatin Tablets
Failed Impurities/Degradation Specifications.
Class III · Low risk
Pitavastatin Tablets
Failed Impurities/Degradation Specifications.
Class III · Low risk
Famciclovir Tablets
Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
Class II · Moderate risk
KIMMTRAK (tebentafusp-tebn)
Subpotent Drug
Class I · High risk
Orajel Baby
Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.