Class II · Moderate risk
Pantoprazole Sodium Delayed-Release Tablets
Discoloration: Expansion of an earlier recall due to the presence of dark brown discoloration on the edges of the tablets.
FDA drug recalls in 2019
Every FDA drug recall initiated in 2019, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,788 recalls, newest first.
Class I · High risk
Lidocaine HCl Injection
Presence of Particulate Matter: One vial was found to contain a hair.
Class III · Low risk
Nystatin Oral Suspension
Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
Class III · Low risk
Thallous Chloride TI 201 Injection
Chemical Contamination: Trace amounts of an impurity was detected in the reagent used to manufacture finished product.
Class II · Moderate risk
Phenobarbital Oral Solution
Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.
Class II · Moderate risk
Bismuth Subsalicylate Oral Suspension 262mg/15mL
Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.
Class II · Moderate risk
Pravastatin Sodium Tablets USP
Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg.
Class II · Moderate risk
Testosterone Cypionate Injection
Presence of Particulate Matter.
Class II · Moderate risk
Testosterone Cypionate Injection
Presence of Particulate Matter.
Class II · Moderate risk
Testosterone Cypionate Injection
Presence of Particulate Matter.
Class III · Low risk
Biotin 10 mg/mL Injection
Failed pH Specification: product does not meet pH label claim.
Class II · Moderate risk
Fayosim (levonorgestrel and ethinyl estradiol)
Failed Impurities/Degradation Specifications: Out-of-specification results observed in related substance test (Any Other Individual Impurity and Total impurities) in Ethinyl Estradiol Tablets USP 0.01mg at 12 month long term stability study.
Class II · Moderate risk
Gavilyte-N
Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon flavor" as an ingredient
Class II · Moderate risk
Class III · Low risk
Diclofenac Sodium Topical Solution
Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.
Class III · Low risk
Repairwear Laser Focus Line Smoothing Cream Broad Spectrum SPF 15
Defective container: Ineffective seal between the cap and jar of the affected product.
Class I · High risk
8.4% Sodium Bicarbonate Injection
Presence of Particulate Matter; glass particulates
Class III · Low risk
Clindamycin Injection
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class III · Low risk
Clindamycin Injection
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class III · Low risk
Clindamycin Injection
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class III · Low risk
Cleocin Phosphate
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class III · Low risk
Cleocin Phosphate
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class III · Low risk
Cleocin Phosphate
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class I · High risk
Blue Fusion Capsules
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared ingredients: Sildenafil, Tadalafil, desmethyl carbodenafil, dithiodesmethyl carbodenafil, scutellarin, and daidzein.
Class II · Moderate risk
Losartan 50mg Tablet
CGMP Deviations; Detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) - N-Methylnitrosobutyric acid (NMBA).