Class II · Moderate risk
Carvedilol Tablets
Failed Tablet/Capsule Specifications: Product exceeds specification for tablet weight and tablet thickness.
FDA Drug Recalls
14,806 recalls, newest first
Class III · Low risk
PULMICORT RESPULES 0.5 mg/2 ml
Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.
Class III · Low risk
PULMICORT RESPULES 0.25 mg/2 ml Budesonide Inhalation Suspension
Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.
Class II · Moderate risk
Furosemide Injection USP
Lack of Assurance of Sterility; possible loose crimp applied to fliptop vial
Class II · Moderate risk
0.9% Sodium Chloride Injection USP
Lack of Assurance of Sterility: There is the potential for solution to leak from the administrative port to the fill tube seal.
Class II · Moderate risk
Belladonna Alkaloids
Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets.
Class III · Low risk
Glycopyrrolate Tablets
Subpotent Drug
Class I · High risk
Reumofan Plus
Marketed without an approved NDA/ANDA: Product may contain undeclared active pharmaceutical ingredients Diclofenac Sodium, Dexamethasone, and Methocarbamol.
Class III · Low risk
buPROPion Hydrochloride Extended - Release Tablets
Failed Dissolution Specifications; 8-hours for the 18-month stability testing point.
Class I · High risk
Mitosol (mitomycin for solution)
Non-Sterility: one or more components of the kit have been found to be contaminated with yeast.
Class I · High risk
Rugby NATURAL IRON SUPPLEMENT Ferrous Sulfate
Labeling; Label Mixup; bottles of Ferrous Sulfate actually contains Meclizine HCl (indicated for motion sickness)
Class II · Moderate risk
Hillyard
Microbial Contamination of Non-Sterile Products: The product may be contaminated with bacteria.
Class III · Low risk
Lac-Hydrin
Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.
Class III · Low risk
Lac-Hydrin
Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.
Class I · High risk
Super Power capsules
Marketed Without An Approved NDA/ANDA: This dietary supplement has been found to contain sildenafil, an FDA approved drug for the treatment of male erectile dysfunction making this an unapproved new drug.
Class II · Moderate risk
12-Hour Sinus
Microbial Contamination of a Non-Sterile Products: 12-Hour Sinus Nasal Spray under various labeling are being recalled due to microbial contamination identified during testing.
Class III · Low risk
Femtrace 0.45 mg
Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles
Class III · Low risk
Femtrace 0.9 mg
Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles
Class I · High risk
SLIMDIA Revolution capsules
Marketed Without an Approved NDA/ANDA: All lots of the dietary supplement Slimdia Revolution are being recalled because they contain sibutramine, a previously approved FDA drug removed from the U.S. marketplace for safety reasons, making it an unapproved new drug.
Class I · High risk
Zicam Extreme Congestion Relief
Microbial Contamination of Non-Sterile Products: Product may be contaminated with Burkholderia cepacia.
Class II · Moderate risk
Taztia XT
Failed Dissolution Specification: Out of a specification result occurred during the 3-month stability testing. Dissolution result at the 4-hour time point was 41% (specification: 20-40%).
Class III · Low risk
Flanax (aluminum hydroxide, magnesium hydroxide, and simethicone)
Defective Container: Product lacks tamper evident breakaway band on cap.
Class I · High risk
CASANOVA Capsules
Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs
Class I · High risk
Mojo nights SUPREME Capsules
Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs
Class I · High risk
Mojo nights Capsules
Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs