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
1,134 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.