Class II · Moderate risk
Divalproex Sodium Delayed Release Tablets USP
Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium.
FDA drug recalls in 2017
Every FDA drug recall initiated in 2017, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,141 recalls, newest first.
Class III · Low risk
Methylphenidate Hydrochloride Extended-release Tablets
Subpotent Drug
Class III · Low risk
Methylphenidate Hydrochloride Extended-release Tablets
Subpotent Drug
Class II · Moderate risk
Fosphenytoin Sodium Injection
Presence of particulate matter
Class III · Low risk
Gabapentin Oral Solution
CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer.
Class II · Moderate risk
0.25% Acetic Acid Irrigation USP
Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap
Class II · Moderate risk
SPIRIVA HandiHaler
Failed Stability Specifications
Class II · Moderate risk
Shiseido Future Solutions LX Triple Points Bonus contains SPF 50+
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Class II · Moderate risk
Shiseido Future Solution LX Luxurious Eye & Lip Collection contains SPF 50+
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Class II · Moderate risk
Shiseido Future Solution LX Discovery Set contains SPF 50+
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Class II · Moderate risk
Shiseido Future Solution LX Universal Defense SPF 50+
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Class II · Moderate risk
bareMinerals Broad Spectrum SPF 50 Daily Prep Lotion
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Class II · Moderate risk
Moexipril Hydrochloride and Hydrocholorothiazide Tablets USP
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
INFeD (Iron Dextran Injection USP)
Failed Stability Specifications: Product stability testing results did not meet specifications for iron content.
Class II · Moderate risk
Codeine-Guaifenesin Oral Solution 10-100 mg/5 mL Antitussive Expectorant
Microbial Contamination of Non-Sterile Products: potentially contamination with the bacteria Burkholderia cepacia
Class III · Low risk
Auryxia (ferric citrate)
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
BodySlim Herbal Advanced technology & Strong formula capsules
Marketed without an approved NDA/ANDA: FDA analysis found the product to contain undeclared sibutramine.
Class II · Moderate risk
Neutrogena Elevated 4-Holiday Trays
Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup area.
Class II · Moderate risk
Neutrogena deep clean purifying whipped foam cleanser
Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup area.
Class II · Moderate risk
Neutrogena Acne Proofing whipped foam cleanser
Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup area.
Class II · Moderate risk
Ephedrine sulfate 5 mg/mL in 0.9% Sodium Chloride 10 mL in Single Dose Syringe
Labeling: Incorrect or Missing Lot and/or Exp Date - product label was missing lot number and beyond use date.
Class III · Low risk
Enoxaparin Sodium
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
Pantoprazole Sodium for Injection
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
Gabapentin Tablets
Labeling: Label Mix-Up.some bottles labeled as Gabapentin 800 mg contain Gabapentin 600 mg
Class II · Moderate risk
Viokace (pancrelipase)
Subpotent Drug: One lot of Viokace is being recalled since product stability testing results did not meet the specifications for enzyme profile.