Class II · Moderate risk
Life-Line tm Catalytic Activated Energy Water
Unapproved new drug
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Indian Herb Paste
Unapproved new drug
Class II · Moderate risk
MAGnesium 2 gm sulfate
Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific to the batch of the labeled product, including Expiration Date. The expiration date included within these 2D barcodes is incorrect and does not match the correct expiration date listed on the face of the label itself.
Class II · Moderate risk
MAGnesium 2gm sulfate
Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific to the batch of the labeled product, including Expiration Date. The expiration date included within these 2D barcodes is incorrect and does not match the correct expiration date listed on the face of the label itself.
Class II · Moderate risk
MAGnesium 1gm sulfate
Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific to the batch of the labeled product, including Expiration Date. The expiration date included within these 2D barcodes is incorrect and does not match the correct expiration date listed on the face of the label itself.
Class II · Moderate risk
Labetalol 20mg
Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific to the batch of the labeled product, including Expiration Date. The expiration date included within these 2D barcodes is incorrect and does not match the correct expiration date listed on the face of the label itself.
Class III · Low risk
Mometasone Furoate Cream
Labeling: Not Elsewhere Classified. Mometasone Furoate Cream has an NDC typographical error.
Class II · Moderate risk
Express Gel Hand Sanitizer
Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Class II · Moderate risk
Quick-Care Foam Hand Sanitizer
Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Class II · Moderate risk
Moisturizing Gel Hand Sanitizer
Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Class II · Moderate risk
Advanced Gel Hand Sanitizer
Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Class II · Moderate risk
Gel Hand Sanitizer
Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Class III · Low risk
Esomeprazole Magnesium Delayed-Release Capsules USP
Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets.
Class III · Low risk
Oxytocin 30 Units added to NS 500 mL
Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Class III · Low risk
Oxytocin 20 Units added to NS 1000 mL
Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Class III · Low risk
Oxytocin 10 Units added to NS 1000 mL
Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Class II · Moderate risk
Fentanyl in 0.9% Sodium Chloride QS 0.5 mL
Labeling: Incorrect expiration date.
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 I · High risk
Levoleucovorin Injection
Presence of Particulate Matter: particulate matter identified as copper salts
Class III · Low risk
Moxifloxacin Ophthalmic Solution USP
Failed Impurities/Degradation Specifications: Out of specification test results in related substance at three-month long term stability study was obtained.
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 III · Low risk
Diltiazem HCl CD capsules
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Class III · Low risk
Cardizem CD
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.