Class I · High risk
Thin and Slim Burn Fat Now Dietary Supplement packaged in 90…
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
FDA drug recalls in 2015
Every FDA drug recall initiated in 2015, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,733 recalls, newest first.
Class I · High risk
MetaPro 360 Metabolic Accelerator Dietary Supplement packaged in…
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
Class I · High risk
Thin and Slim MaxOut Body Max Out FX Fat Burner with Ephedra…
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
Class I · High risk
The People's Chemist Thermo FX Barely Legal Thermogenic Aid
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
Class I · High risk
Thin and Slim Fataway Ultimate Stack with Chromium
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
Class II · Moderate risk
Doxycycline Hyclate Tablets
Labeling: Wrong Bar Code
Class III · Low risk
Lamivudine Oral Solution
Labeling: Incorrect or Missing Lot and/or Exp. Date - Firm received a customer complaint that the expiration date printed on the unit carton (5/18) does not match the expiration date on the bottle label (5/17).
Class II · Moderate risk
MIDAZOLAM HCl in 0.9% Sodium Chloride Injection
Subpotent Drug
Class II · Moderate risk
MIDAZolam HCl 0.1 mg/mL in 5% DEXTROSE 2.5 mL syringe
Subpotent Drug
Class II · Moderate risk
Midazolam HCl in 0.9% Sodium Chloride Injection
Subpotent Drug
Class II · Moderate risk
LIDocaine HCl 1% BUFFERED WITH SODIUM BICARBONATE Injection
Subpotent Drug
Class II · Moderate risk
HEPARIN Sodium in 0.45% Sodium Chloride
Stability Data Does Not Support Expiry
Class II · Moderate risk
HEParin Sodium 0.5 USP UNITS/mL in 0.225% SODIUM CHLORIDE
Stability Data Does Not Support Expiry
Class I · High risk
fentaNYL Citrate 50 mcg/mL in Sterile Water for Injection
Subpotent Drug
Class I · High risk
fentaNYL CITRATE 4 MCG/mL in 0.9% SODIUM CHLORIDE Injection
Subpotent Drug
Class I · High risk
fentaNYL citrate in 0.9% Sodium Chloride Injection
Subpotent Drug
Class I · High risk
fentaNYL CITRATE 25 mcg/mL in 5% DEXTROSE Injection
Subpotent Drug
Class I · High risk
fentaNYL Citrate 1 MCG/mL in 0.9% Sodium Chloride Injection
Subpotent Drug
Class I · High risk
Atropine Sulfate Injection Solution
Subpotent Drug
Class I · High risk
fentaNYL citrate in 0.9% Sodium Chloride Injection
Subpotent Drug
Class II · Moderate risk
Class II · Moderate risk
Class III · Low risk
Hydrocortisone and Acetic Acid Otic Solution
Defective Container: Product missing safety seal around the neck of the bottle. The product label indicates, "Tamper Evident: Do not use if printed seal around cap is broken or missing." Because the product is missing the approved component and is not consistent with the labeling, the lot is being recalled.
Class II · Moderate risk
Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution
Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process
Class II · Moderate risk
Ketamine Hydrochloride Injection
Defective Container: There were customer complaints of cracked and leaking glass vials.