Class II · Moderate risk
FDA drug recalls in 2017
Every FDA drug recall initiated in 2017, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,141 recalls, newest first.
Class II · Moderate risk
Class II · Moderate risk
Fosphenytoin Sodium Injection
Presence of Particulate Matter
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Class II · Moderate risk
Doctor Manzanilla Cough & Cold
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk
Doctor Manzanilla Allergy & Decongestant Relief
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Class I · High risk
Vancomycin Hydrochloride for Injection
Presence of Particulate Matter: glass particulate found in vial
Class III · Low risk
Enalapril Maleate Tablets
Failed Stability Specifications
Class I · High risk
PIYANPING Anti-Itch
Incorrect Product Formulation: product contains dexamethasone instead of hydrocortisone.
Class III · Low risk
Propafenone Hydrochloride tablets
Failed moisture limits: Out of specification for moisture content.
Class II · Moderate risk
Choice Antibacterial Hand Soap
GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump.
Class II · Moderate risk
Mild Healthcare Antibacterial Hand Soap
GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump.
Class II · Moderate risk
Option Systems Antibacterial Foaming Hand Wash
GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump
Class II · Moderate risk
Ketorolac Trom 30 mg/mL Injection
Crystallization: Product is being recalled due to the manufacturer's recall due to the presence of visible particulate in vials that has been identified as crystalline ketorolac calcium salt.
Class II · Moderate risk
Levophed (norepinephrine bitartrate)
Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
Class II · Moderate risk
HYDROmorphone HCl Injection
Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
Class II · Moderate risk
Ninjacof-A
Microbial contamination of Non-sterile Products; potential B. cepacia contamination
Class II · Moderate risk
Ninjacof (Chlophedianol HCL 12.5 mg and Pyrilamine Maleate 12.5 mg)
Microbial contamination of Non-sterile Products; potential B. cepacia contamination
Class II · Moderate risk
Nose to Toes Skin Antisepsis
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Class II · Moderate risk
Skin antisepsis and oral cleansing. Contains Three 2-packs of 2%…
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Class II · Moderate risk
Q Care RX Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Class II · Moderate risk
Q Care Oral Cleansing & Suctioning System compatible with 0.12% Chlorhexidine Gluconate
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products