Class II · Moderate risk
Haloperidol Decanoate Injection 50mg/mL
Lack of Assurance of Sterility: Media fill with bacterial contamination
FDA Drug Recalls
721 recalls, newest first
Class II · Moderate risk
Methocarbamol Injection USP 1
Lack of Assurance of Sterility: Media fill with bacterial contamination
Class II · Moderate risk
Atorvastatin Calcium Tablets USP 40 mg
Failed dissolution specifications: lower than specifications
Class I · High risk
Levetiracetam 0.75% in Sodium Chloride Injection 1
LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.
Class II · Moderate risk
Propafenone Hydrochloride Extended-Release Capsules
CGMP Deviations
Class II · Moderate risk
Propafenone Hydrochloride Extended-Release Capsules USP
CGMP Deviations
Class II · Moderate risk
Pravastatin Sodium Tablets
CGMP Deviations
Class II · Moderate risk
Pravastatin Sodium Tablets
CGMP Deviations
Class II · Moderate risk
Cetirizine Hydrochloride Tablets
CGMP Deviations
Class II · Moderate risk
Acetaminophen and Ibuprofen
CGMP Deviations
Class II · Moderate risk
Naproxen Sodium Tablets
CGMP Deviations
Class II · Moderate risk
Saxagliptin Tablets
CGMP Deviations
Class II · Moderate risk
Clindamycin Hydrochloride Capsules
CGMP Deviations
Class II · Moderate risk
Lacosamide Tablets 150mg
CGMP Deviations
Class II · Moderate risk
Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg
CGMP Deviations
Class II · Moderate risk
Pravastatin Sodium Tablets
CGMP Deviations
Class II · Moderate risk
Colesvelam Hydrocholoride Tablets 625mg
CGMP Deviations
Class II · Moderate risk
Rosuvastatin Tablets 40mg
CGMP Deviations
Class II · Moderate risk
Prochlorperazine Maleate Tablets
CGMP Deviations
Class II · Moderate risk
Lacosamide Tablets
CGMP Deviations
Class II · Moderate risk
Carvedilol Tablets
CGMP Deviations
Class II · Moderate risk
Ranolazine Extended-Release Tablets 1000mg
CGMP Deviations
Class II · Moderate risk
Teriflunomide Tablets
CGMP Deviations
Class II · Moderate risk
Solifenacin Succinate Tablets 5mg
CGMP Deviations
Class II · Moderate risk
Saxagliptin Tablets 5mg
CGMP Deviations