Class II · Moderate risk
Gabapentin Capsules
Defective container; blister packaging inadequately sealed.
FDA Drug Recalls
676 recalls · Class II, newest first
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 II · Moderate risk
KIMMTRAK (tebentafusp-tebn)
Subpotent Drug
Class II · Moderate risk
LIDOcaine HCL Sterile Injection
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II · Moderate risk
LIDOcaine HCL Sterile Injection
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II · Moderate risk
KETAmine Hydrochloride Injection
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II · Moderate risk
KETAmine Hydrochloride Injection
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II · Moderate risk
BUPIVAcaine HCL Sterile injection
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II · Moderate risk
LIDOcaine HCl Injection
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II · Moderate risk
Testo-200
Marketed Without an Approved NDA/ANDA
Class II · Moderate risk
Icosapent Ethyl Capsules 1 gram
Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents.
Class II · Moderate risk
Gentamicin Injection
Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Class II · Moderate risk
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Azelastine HCl Ophthalmic Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Ketorolac Tromethamine Ophthalmic Solution
Lack of Assurance of Sterility
Class II · Moderate risk
DOBUTamine Injection
Discoloration; discolored solution from cracked vials
Class II · Moderate risk
Lacosamide Oral Solution
Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Fluoxetine Tablets
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Class II · Moderate risk
Fluoxetine Tablets
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Class II · Moderate risk
Metoclopramide Tablets
Presence of foreign tablets/capsules.
Class II · Moderate risk
Cephalexin for Oral Suspension
Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.
Class II · Moderate risk
Cephalexin for Oral Suspension
Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.
Class II · Moderate risk
Spectrum Advanced Gel Hand Sanitizer
Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol