Class I · High risk
Zicam Nasal Allclear
Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
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 I · High risk
Zicam Cold Remedy Medicated Nasal Swabs
Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
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 I · High risk
Sulfamethoxazole and Trimethoprim Tablets
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
Class II · Moderate risk
Testo-200
Marketed Without an Approved NDA/ANDA
Class II · Moderate risk
Gentamicin Injection
Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Class III · Low risk
Levothyroxine Sodium Tablets
Presence of a foreign substance: black hair found embedded in tablet.
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
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
Class II · Moderate risk
Acetaminophen Tablets
cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
Class II · Moderate risk
Nicotinamide adenine dinucleotide
Lack of Assurance of Sterility
Class II · Moderate risk
Tirzepatide/Cyanocobalamin Injectable
Lack of Assurance of Sterility