Class III · Low risk
Duet DHA 430 ec
Subpotent; Beta carotene (Vitamin A)
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 III · Low risk
Duet DHA 430
Subpotent; Beta carotene (Vitamin A)
Class III · Low risk
NataChew
Subpotent; Beta carotene (Vitamin A)
Class III · Low risk
Duet DHA 400 ec
Subpotent; Beta carotene (Vitamin A)
Class III · Low risk
Duet DHA 400
Subpotent; Beta carotene (Vitamin A)
Class III · Low risk
Duet DHA Balanced
Subpotent; Beta carotene (Vitamin A)
Class III · Low risk
LA MER the spf 18 fluid tint
Subpotent drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunscreen effectiveness may be less than labeled
Class III · Low risk
LA MER the spf 18 fluid tint
Subpotent Drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunscreen effectiveness may be less than labeled
Class III · Low risk
LA MER the spf 18 fluid tint
Subpotent Drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunscreen effectiveness may be less than labeled
Class II · Moderate risk
Sodium Chloride Injection
Presence of Particulate Matter: Confirmed customer report of visible particulate in the form of an orange or rust colored ring embedded in between the plastic layers of the plastic vial.
Class I · High risk
Silver Sword capsules
Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that the products was found to contain sildenafil, an undeclared active pharmaceutical ingredient.
Class I · High risk
Clalis capsules
Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that the products was found to contain sildenafil, an undeclared active pharmaceutical ingredient.
Class II · Moderate risk
Latanoprost Ophthalmic Solution
Lack of Assurance of Sterility: Failed at expiry for Preservative Effectiveness Test (PET), therefore the product may be susceptible to microbial growth before the expiry date.
Class II · Moderate risk
Oxytocin Injection
Subpotent Drug; 15-month stability test station
Class II · Moderate risk
Gastrografin
Presence of foreign substance: One lot of the product may contain black foreign particles
Class II · Moderate risk
Merrem I.V.
Presence of Precipitate; potential for incomplete constitution upon addition of diluent.
Class II · Moderate risk
Estarylla (Norgestimate and Ethinyl Estradiol)
Contraceptive Tablets out of Sequence: A placebo tablet was found in a row of active tablets.
Class III · Low risk
BFF's are COOL! Justice
Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.
Class III · Low risk
yum yum bubble gum Justice
Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.
Class III · Low risk
YOU CANT HANDLE THIS Justice
Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.
Class III · Low risk
I LOVE BACON Justice
Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.
Class III · Low risk
I MUSTACHE YOU TO BE MY BFF Justice
Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.
Class III · Low risk
GIRLS ROCK Justice
Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.
Class III · Low risk
Grapefruit anti bac Justice
Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.
Class III · Low risk
Lemon anti bac Justice
Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.