Class III · Low risk Terminated
Clobetasol Propionate Emollient Cream 0.05%
Reason Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study.
FDA Drug Recalls
17,898 recalls, newest first
Class I · High risk Terminated
the silver bullet 10x Capsules
Reason Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil
Class II · Moderate risk Terminated
LET Gel 4%
Reason 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 Terminated
BromSite
Reason Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance.
Class II · Moderate risk Terminated
Alprazolam Tablets
Reason Failed Impurities/Degradation Specifications: Elevated levels of a known impurity detected during 6-month RT stability interval.
Class II · Moderate risk Terminated
Fexofenadine HCl Tablets
Reason Failed Impurities/Degradation Specifications: Related compound results obtained during routine stability testing was slightly elevated above specification.
Class II · Moderate risk Completed
Irbesartan and Hydrochlorothiazide Tablets
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Class II · Moderate risk Completed
Irbesartan and Hydrochlorothiazide Tablets
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Class II · Moderate risk Completed
Irbesartan and Hydrochlorothiazide Tablets
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Class II · Moderate risk Completed
Irbesartan and HydrochlorothiazideTablets
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Class II · Moderate risk Completed
Irbesartan Tablets 300 mg 90 count Rx only Manufactured by…
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Class II · Moderate risk Terminated
NORepinephrine 4 mg added to 5% Dextrose 250 mL Bag
Reason Labeling: Label mix-up
Class II · Moderate risk Terminated
NORepinephrine 16 mg added to 0.9% Sodium Chloride
Reason Labeling: Label mix-up
Class II · Moderate risk Terminated
Docusate Sodium
Reason Labeling: Label mix-up: Secondary carton may be labeled as Gabapentin 300mg instead of Docusate Sodium 100mg softgel caps.
Class II · Moderate risk Terminated
Infants' Ibuprofen
Reason Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Class II · Moderate risk Terminated
infants* IBUPROFEN
Reason Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Class II · Moderate risk Terminated
Infants' Ibuprofen
Reason Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Class II · Moderate risk Terminated
HEPERAIN 50 mg/50 mL
Reason 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 Terminated
Fluocinolone Acetonide Topical Solution
Reason 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 Terminated
Ezetimibe and Simvastatin Tablets 10mg/80 mg
Reason Presence of Foreign Substance: Product complaint of black speckles observed on tablets.
Class III · Low risk Terminated
Clobetasol Propionate Topical Solution USP
Reason Defective Container; complaints of leakage.
Class II · Moderate risk Terminated
Losartan Potassium Tablets
Reason 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 Terminated
Lipoic Acid Injection
Reason Presence of Particulate Matter: filmy/cloudy particulate observed in vial.
Class II · Moderate risk Terminated
Cephalexin for Oral Suspension USP 250mg/5 mL
Reason 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 Terminated
5K Premium Enhancement capsule
Reason Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil