Class III · Low risk
Kids' Cough and Chest Congestion
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
FDA Drug Recalls
18,003 recalls, newest first
Class III · Low risk
Adult Cough and Chest Congestion
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Class II · Moderate risk
Thiamine HCl 0.9% Sodium Chloride Injection USP
cGMP violations
Class II · Moderate risk
EPINEPHrine 0.9% Sodium Chloride Injection USP
cGMP violations
Class II · Moderate risk
Oxytocin 0.9% Sodium Chloride Injection USP
cGMP violations
Class II · Moderate risk
NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP
cGMP violations
Class II · Moderate risk
NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP
cGMP violations
Class II · Moderate risk
Class II · Moderate risk
Phenylephrine HCl 0.9% Sodium Chloride Injection USP
cGMP violations
Class II · Moderate risk
Phenylephrine HCl 0.9% Sodium Chloride Injection USP
cGMP violations
Class II · Moderate risk
Phenylephrine HCl 0.9% Sodium Chloride Injection USP
cGMP violations
Class II · Moderate risk
Phenylephrine HCl 0.9% Sodium Chloride Injection USP
CGMP violations
Class II · Moderate risk
Dapsone Gel 7.5%
Crystallization
Class II · Moderate risk
Ryaltris (olopatadine hydrochloride and mometasone fluorate)
Defective Delivery System: The dip tube is clogged causing the spray not to work.
Class II · Moderate risk
Atorvastatin Calcium Tablets
Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.
Class II · Moderate risk
Pluvicto
CGMP deviations
Class I · High risk
Veklury (remdesivir)
Presence of Particulate Matter: Presence of glass particle.
Class II · Moderate risk
EnviroClean Hand Sanitizer Gel
CGMP deviations
Class I · High risk
Vail-Bon Jie Yang Wan capsules
Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone and chlorpheniramine.
Class I · High risk
Atovaquone Oral Suspension
Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
Class II · Moderate risk
Refresh LACRI-LUBE
Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Class II · Moderate risk
Refresh P.M.
Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Class II · Moderate risk
Proparacaine Hydrochloride Ophthalmic Solution
Temperature abuse: Products exposed to improper temperature above drug label specifications.
Class II · Moderate risk
Hylenex recombinant
cGMP Deviations: Temperature excursion
Class II · Moderate risk
First Aid Antiseptic Ointment
Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The inactive ingredients in the actual product are polyethylene glycol 400 , polyethylene glycol 4000.