Class II · Moderate risk
Fentanyl in 0.9% Sodium Chloride QS 0.5 mL
Labeling: Incorrect expiration date.
FDA Drug Recalls
11,818 recalls · Class II, newest first
Class II · Moderate risk
Moisturizing Lubricant Eye Drops
Failed Stability Specification: out of specification results for Sodium Perborate
Class II · Moderate risk
0.9% Sodium Chloride Injection
CGMP Deviations
Class II · Moderate risk
Dymista (azelastine hydrochloride and fluticasone propionate)
Defective Container: Potential for broken glass in the neck area of the glass bottles.
Class II · Moderate risk
Divalproex Sodium Extended-release Tablets
Failed Dissolution Specifications: Out of specification results observed for high dissolution.
Class II · Moderate risk
Ephedrine Sulfate
Lack of assurance of sterility.
Class II · Moderate risk
LET Gel 4%
Labeling: Incorrect or Missing Lot and/or Exp Date: Labels are missing lot and expiration date and are printed as Lot# YYYDDYY@XX with a Beyond Use Date: MM/DD/YYY.
Class II · Moderate risk
BromSite (bromfenac ophthalmic solution)
Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance.
Class II · Moderate risk
Alprazolam Tablets
Failed Impurities/Degradation Specifications: Elevated levels of a known impurity detected during 6-month RT stability interval.
Class II · Moderate risk
Fexofenadine HCl Tablets
Failed Impurities/Degradation Specifications: Related compound results obtained during routine stability testing was slightly elevated above specification.
Class II · Moderate risk
NORepinephrine 4 mg added to 5% Dextrose 250 mL Bag
Labeling: Label mix-up
Class II · Moderate risk
NORepinephrine 16 mg added to 0.9% Sodium Chloride
Labeling: Label mix-up
Class II · Moderate risk
Docusate Sodium
Labeling: Label mix-up: Secondary carton may be labeled as Gabapentin 300mg instead of Docusate Sodium 100mg softgel caps.
Class II · Moderate risk
Infants' Ibuprofen
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Class II · Moderate risk
infants* IBUPROFEN
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Class II · Moderate risk
Infants' Ibuprofen
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Class II · Moderate risk
HEPERAIN 50 mg/50 mL
Labeling; Label Error on Declared Strength; label incorrectly states the concentration as 50 mg/50 mL (1 mg/mL) rather than the fully accurate concentration as 50 Units/50 mL (1 Unit/mL)
Class II · Moderate risk
Fluocinolone Acetonide Topical Solution
Failed Impurities/Degradation Specifications: Expansion of October 2018 recall due to elevated out of specification results for total impurities that have been chemically identified as oxidative degradation products of the fluocinolone active pharmaceutical ingredient.
Class II · Moderate risk
Ezetimibe and Simvastatin Tablets 10mg/80 mg
Presence of Foreign Substance: Product complaint of black speckles observed on tablets.
Class II · Moderate risk
Losartan Potassium Tablets
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
Class II · Moderate risk
Lipoic Acid Injection
Presence of Particulate Matter: filmy/cloudy particulate observed in vial.
Class II · Moderate risk
Cephalexin for Oral Suspension USP 250mg/5 mL
CGMP Deviations; presence of extraneous material in the was observed in area that is between the primary package that is heat sealed and secondary packaging (poly-woven bag) of sucrose (an excipient) used in the finished product.
Class II · Moderate risk
Cephalexin for Oral Suspension USP
CGMP Deviation; manufacturing batch record could not be located
Class II · Moderate risk
Lidocaine gel 1%
Lack of sterility assurance.
Class II · Moderate risk
Glutathione liquid
Lack of sterility assurance.