Class II · Moderate risk
PHENOBARBITAL Sodium Injection
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
FDA drug recalls in 2022
Every FDA drug recall initiated in 2022, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,390 recalls, newest first.
Class II · Moderate risk
PAPAVERINE HYDROCHLORIDE Injection
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class II · Moderate risk
TETRACAINE 1% Tetracaine HCI Injection
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class II · Moderate risk
Epinephrine Injection 8 mg per 250 mL in 0.9% Sodium Chloride
Defective container
Class II · Moderate risk
Phenylephrine HCl Injection in 0.9% Sodium Chloride
Defective container
Class II · Moderate risk
Phenylephrine HCl Injection 50 mg per 250 mL in 0.9% Sodium Chloride
Defective container
Class II · Moderate risk
Phenylephrine HCl Injection 40 mg per 250 mL in 0.9% Sodium Chloride
Defective container
Class II · Moderate risk
Norepinephrine Bitartrate Injection 8 mg per 250 mL in 0.9% Sodium Chloride
Defective container
Class II · Moderate risk
Class II · Moderate risk
Norepinephrine Bitartrate Injection 4mg per 250 mL in 0.9% Sodium Chloride
Defective container
Class II · Moderate risk
Sucralfate Oral Suspension
Labeling: Label Mix-Up
Class III · Low risk
Risedronate Sodium Tablets
FAILED CONTENT UNIFORMITY SPECIFICATIONS
Class II · Moderate risk
Rock Town - Distillery - Hand Sanitizer
CGMP Deviations: FDA analysis found product to contain acetal and acetaldehyde above specification limits.
Class I · High risk
Meclizine Hydrochloride Tablets USP
Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydrochloride Tablets contain bottles incorrectly labeled as PredniSONE Tablets. The tablets in the bottles are Meclizine Hydrochloride
Class II · Moderate risk
Sincalide Lyophilized powder for reconstitution Each ML contains: Mannitol 170mg
Super Potent and Failed Reconstitution Time
Class III · Low risk
Hydroxocobalamin B12 1mg/mL
Sub Potent
Class III · Low risk
Sb-4
Sub Potent
Class III · Low risk
T-105
Super Potent
Class III · Low risk
Formula F9
Sub Potent
Class II · Moderate risk
NAD+ Nicotinamide Adenine Dinucleotide
Product found to be Sub Potent or Exceeded reconstitution time
Class II · Moderate risk
Class II · Moderate risk
Glutathione 200mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Vitamin D3 50
Lack of Assurance of Sterility
Class II · Moderate risk
Vitamin B-Complex Preservative Free
Lack of Assurance of Sterility
Class II · Moderate risk
Vitamin B-Complex
Lack of Assurance of Sterility