Class III · Low risk
Estradiol Transdermal System
Failed Impurities/Degradation Specifications.
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 III · Low risk
Pregabalin Capsules 50mg
Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tablet identified as pantoprazole tablet 20mg.
Class II · Moderate risk
Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension
Lack of Assurance of Sterility
Class II · Moderate risk
Klarity-C (cyclosporine)
Lack of Assurance of Sterility
Class II · Moderate risk
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL…
Lack of Assurance of Sterility
Class II · Moderate risk
Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials…
Lack of Assurance of Sterility
Class II · Moderate risk
Moxifloxacin 0.8 mg/0.8 mL Preservative-Free 0.8mL Single-Use…
Lack of Assurance of Sterility
Class II · Moderate risk
Dexamethasone-Moxifloxacin- Ketorolac
Lack of Assurance of Sterility
Class II · Moderate risk
Dexamethasone-Moxifloxacin
Lack of Assurance of Sterility
Class II · Moderate risk
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL…
Lack of Assurance of Sterility
Class II · Moderate risk
Rizatriptan Benzoate Orally Disintegrating Tablets
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Class II · Moderate risk
Rizatriptan Benzoate Orally Disintegrating Tablets
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Class III · Low risk
Cephalexin for Oral Suspension
Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'
Class III · Low risk
Cephalexin for Oral Suspension
Labeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP equivalent to 5g' on the back label instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g'
Class III · Low risk
Cephalexin for Oral Suspension
Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'
Class III · Low risk
Cephalexin for Oral Suspension
Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP equivalent to 2.5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g
Class III · Low risk
Cephalexin for Oral Suspension
Labeling: Not Elsewhere Classified: Front label states 100 Tablets instead of 100 ml and on the back label 'Each Tablet contains' instead of 'Each Bottle contains' No total dose per bottle listed should be 2.5 g'
Class II · Moderate risk
Rizatriptan Benzoate Tablets USP
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Class II · Moderate risk
Rizatriptan Benzoate Tablets USP
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Class II · Moderate risk
Duloxetine Delayed-Release Cap USP 30mg
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II · Moderate risk
Drug Vial Label: Zilretta¿
Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C.
Class II · Moderate risk
Losartan Potassium and Hydrochlorothiazide Tablets
Presence of foreign substance: plastic-like substance.
Class II · Moderate risk
Metoprolol Tartrate Tablets USP
Presence of Foreign Substance: metal in tablet
Class III · Low risk
Sirolimus Tablets 1mg Tablets 100-count bottle
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Meijer Magnesium Citrate Saline Laxative Oral Solution Dye Free
Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria