Class I · High risk
Coppertone Pure & Simple 50 Sunscreen Spray
Chemical contamination; presence of benzene
FDA drug recalls in 2021
Every FDA drug recall initiated in 2021, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,152 recalls, newest first.
Class II · Moderate risk
The Natural Dentist Healthy Balance Peppermint Sage
Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Menthol with UPC 7 14132 00071 4 instead of Peppermint Oil and Sage Oil with UPC 7 14132 00073 8
Class III · Low risk
Butalbital
Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label
Class III · Low risk
Butalbital
Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label
Class II · Moderate risk
Potassium Chloride Extended-Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Artesunate for Injection
Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance.
Class I · High risk
Glucagon Emergency Kit for Low Blood Sugar
SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. There was also a lack of full drug effect upon administration.
Class II · Moderate risk
Hydroquinone USP
Finished product specification did not meet USP specifications.
Class II · Moderate risk
Testosterone Cypionate Testosterone Propionate
Lack of Assurance of Sterility
Class II · Moderate risk
AirDuo Digihaler 232/14
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class II · Moderate risk
AirDuo Digihaler 113/14
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class II · Moderate risk
AirDuo Digihaler 55/14
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class II · Moderate risk
AirDuo Digihaler 232/14
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class II · Moderate risk
AirDuo Digihaler 113/14
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class II · Moderate risk
Potassium Chloride 40 mEq in 0.9% Sodium Chloride 270 mL NS
Lack of Assurance of Sterility
Class II · Moderate risk
Sodium Phenylbutyrate Powder
Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.
Class II · Moderate risk
Cleaning Solutions Foaming Hand Sanitizer
CGMP Deviations: Use of this product may cause possible infection/ irritation of the skin and/or soft tissues.
Class II · Moderate risk
ceFAZolin 3 G in 0.9% Sodium Chloride
Lack of sterility assurance.
Class II · Moderate risk
ceFAZolin
Lack of sterility assurance.
Class II · Moderate risk
Morphine Sulfate Injection
Defective container: Cracked vials leading to lack of sterility assurance
Class II · Moderate risk
GlipiZIDE Extended-Release Tablets
Failed Dissolution Specifications: results were above specification.
Class II · Moderate risk
Valproic Acid Oral Solution
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Class II · Moderate risk
Zonisamide 100 mg Capsules
CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Class III · Low risk
Candesartan Cilexetil Tablets
Failed Impurities/Degradation Specifications; out of specification for Related Compound
Class II · Moderate risk
Rocuronium Bromide Injection 50mg/5 mL
Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the flip cap vial, "WARNING: PARALYZING AGENT"