Class II · Moderate risk
NORepinephrine 16 mg added to 0.9% Sodium Chloride
Labeling: Label mix-up
FDA Drug Recalls
1,563 recalls, newest first
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 III · Low risk
Clobetasol Propionate Topical Solution USP
Defective Container; complaints of leakage.
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 I · High risk
5K Premium Enhancement capsule
Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil
Class II · Moderate risk
Cephalexin for Oral Suspension USP
CGMP Deviation; manufacturing batch record could not be located
Class I · High risk
Vecuronium Bromide for Injection 20 mg* *1mg/mL when reconstituted to 20 mL Lyophilized
Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
Class I · High risk
Vecuronium Bromide for Injection 10 mg*
Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
Class II · Moderate risk
Lidocaine gel 1%
Lack of sterility assurance.
Class II · Moderate risk
Glutathione liquid
Lack of sterility assurance.
Class II · Moderate risk
Cyclosporin liquid 0.05%
Lack of sterility assurance.
Class II · Moderate risk
Cyclosporin liquid 0.2%
Lack of sterility assurance.
Class II · Moderate risk
Cyclosporin liquid 0.5%
Lack of sterility assurance.
Class II · Moderate risk
Cyclosporin liquid 1%
Lack of sterility assurance.
Class II · Moderate risk
Vitamin B12 liquid 1000mcg/ml
Lack of sterility assurance.
Class II · Moderate risk
Testosteron Cypionate liquid 200mg/ml
Lack of sterility assurance.
Class II · Moderate risk
Methocarbamol liquid 100mg/ml
Lack of sterility assurance.