Class II · Moderate risk
DOBUTamine in 5% Dextrose Injection
Lack of Assurance of Sterility: Confirmed report of leaking in the primary container.
FDA drug recalls in 2013
Every FDA drug recall initiated in 2013, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
2,085 recalls, newest first.
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Class I · High risk
Black Ant
Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined the Vicerex product contains undeclared tadalafil and the Black Ant product contains undeclared sildenafil. Tadalafil and sildenafil are FDA-Approved drugs used to treat male erectile dysfunction (ED), making the Vicerex and the Black Ant products unapproved new drugs.
Class I · High risk
Vicerex A Powerful And Fast Acting Male Sexual Enhancer
Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined the Vicerex product contains undeclared tadalafil and the Black Ant product contains undeclared sildenafil. Tadalafil and sildenafil are FDA-Approved drugs used to treat male erectile dysfunction (ED), making the Vicerex and the Black Ant products unapproved new drugs.
Class III · Low risk
Amoxicillin for Oral Suspension
Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin powder on the inner foil seal of the bottles.
Class II · Moderate risk
Cornea Coat
Marketed without an Approved NDA/ANDA.
Class II · Moderate risk
Ropinirole hydrochloride tablets
Labeling: Label Error on Declared Strength- Unopened bottles of Ropinirole USP 3 mg tablets was found to be incorrectly labeled as Ropinirole USP 4 mg tablets..
Class II · Moderate risk
Pyridoxine 100mg/ml Inj MDV
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
Meperidine 100mg/ml MDV
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
Lidocaine 2% Inj MDV
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
M.I.C.+B12 Inj MDV: 3x50ml
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
Glutathione 200mg/ml Inj SDV: 3x50ml 14 day expiration
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
Gentamicin 24mg/60ml Irrigation
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
Renacidin Irrigation: 1000 ml
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
Hydroxyprogesterone Inj 250mg/ml MDV
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.