Class II · Moderate risk Terminated
Shiseido Future Solution LX Universal Defense SPF 50+
Reason GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
FDA Drug Recalls
14,801 recalls, newest first
Class II · Moderate risk Terminated
bareMinerals Broad Spectrum SPF 50 Daily Prep Lotion
Reason GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Class II · Moderate risk Terminated
Moexipril Hydrochloride and Hydrocholorothiazide Tablets USP
Reason Failed Impurities/Degradation Specifications: High out of specification test result for the Moexipril Diketopiperazine impurity was obtained during routine stability testing.
Class II · Moderate risk Terminated
INFeD
Reason Failed Stability Specifications: Product stability testing results did not meet specifications for iron content.
Class II · Moderate risk Terminated
Codeine-Guaifenesin Oral Solution 10-100 mg/5 mL Antitussive Expectorant
Reason Microbial Contamination of Non-Sterile Products: potentially contamination with the bacteria Burkholderia cepacia
Class III · Low risk Terminated
Auryxia
Reason Presence of Foreign Substance: Reports have been received of damaged StripPax packets containing silica gel desiccant potentially allowing the silica gel granules to make contact with Auryxia tablets in the bottle.
Class I · High risk Terminated
BodySlim Herbal Advanced technology & Strong formula capsules
Reason Marketed without an approved NDA/ANDA: FDA analysis found the product to contain undeclared sibutramine.
Class II · Moderate risk Terminated
Neutrogena Elevated 4-Holiday Trays
Reason Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup area.
Class II · Moderate risk Terminated
Neutrogena deep clean purifying whipped foam cleanser
Reason Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup area.
Class II · Moderate risk Terminated
Neutrogena Acne Proofing whipped foam cleanser
Reason Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup area.
Class II · Moderate risk Terminated
Ephedrine sulfate 5 mg/mL in 0.9% Sodium Chloride 10 mL in Single Dose Syringe
Reason Labeling: Incorrect or Missing Lot and/or Exp Date - product label was missing lot number and beyond use date.
Class III · Low risk Terminated
Enoxaparin Sodium
Reason Labeling: Label Error on Declared Strength. A single syringe labeled as 150 mg/1.0 mL was found packaged in a blister labeled as 120 mg/mL
Class I · High risk Terminated
Pantoprazole Sodium for Injection
Reason Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass
Class II · Moderate risk Terminated
Gabapentin Tablets
Reason Labeling: Label Mix-Up.some bottles labeled as Gabapentin 800 mg contain Gabapentin 600 mg
Class II · Moderate risk Terminated
Viokace
Reason Subpotent Drug: One lot of Viokace is being recalled since product stability testing results did not meet the specifications for enzyme profile.
Class III · Low risk Terminated
Bull Capsules
Reason Marketed without an Approved NDA/ANDA; product found to be tainted with sildenafil
Class II · Moderate risk Terminated
All sterile drug preparations remaining within expiry prepared…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
All sterile drug preparations remaining within expiry prepared…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
All sterile drug preparations remaining within expiry prepared…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
All sterile drug preparations remaining within expiry prepared…
Reason Lack of sterility assurance.
Class I · High risk Terminated
BLUE PEARL capsules
Reason Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.
Class II · Moderate risk Terminated
Valsartan Tablets
Reason Failed Tablet/Capsule Specifications: confirmed customer complaint of thicker and heavier tablets in bottle.
Class III · Low risk Terminated
Penicillin V Potassium for Oral Solution
Reason Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.
Class II · Moderate risk Terminated
Vertra Elemental Resistance
Reason CGMP Deviations: products manufactured in a manner that may impact product quality that includes but is not limited to failed viscosity.
Class III · Low risk Terminated
Duloxetine Delayed-Release Capsules USP
Reason Failed Dissolution Specification