Class II · Moderate risk
Norepinephrine Bitartrate Injection USP 4 mg/4 mL
Lack of Assurance of Sterility
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.
- Total recalls
- 1,152
- Class I (high risk)
- 124
- Currently ongoing
- 84
- Most recent
- Dec 31, 2021
Class II · Moderate risk
MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL
Lack of Assurance of Sterility
Class II · Moderate risk
Metoprolol Tartrate Tablets
Complaint received of foreign matter (metal) embedded in tablet.
Class II · Moderate risk
Metformin 750 mg Extended Release NDC # 70518-2920-00
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Class II · Moderate risk
Pioglitazone Tablets USP
Superpotent and Failed Tablet/Capsule Specifications
Class II · Moderate risk
Cefixime 400 mg capsule
Failed Impurities/Degradation Specifications
Class III · Low risk
Oxycodone Hydrochloride Tablets
Out-of-specification impurity test result observed at 18-month long term stability time point.
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets
CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Class II · Moderate risk
Nitroglycerin Lingual Spray
Defective Delivery System
Class III · Low risk
Gatifloxacin Ophthalmic Solution
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
Class II · Moderate risk
Medroxyprogesterone Acetate Injection
Lack of Assurance of Sterility
Class I · High risk
SENNA Syrup
Microbial Contamination of Non-Sterile Product
Class II · Moderate risk
Cefixime Capsules
Failed impurities/degradation specifications
Class II · Moderate risk
Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Penicillin V Potassium for Oral Solution
Subpotent
Class I · High risk
Clobetasol Propionate Ointment USP
Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria
Class II · Moderate risk
Brinzolamide Ophthalmic Suspension
Defective Container: The notch in the cap that fits into the nozzle of the dropper could break off and block the dropper possibly resulting in the product not dispensing.
Class II · Moderate risk
Diclofenac Sodium Topical Solution 1.5%
Defective Container: Leaking containers.
Class II · Moderate risk
NaturesPlus Advanced Therapeutics Glucosamine Chondroitin MSM Ultra Rx- Joint Cream
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCT: microbial contaminant identified as Pluralibacter gergoviae.
Class II · Moderate risk
Trypan Blue 0.03%
CGMP Deviations
Class II · Moderate risk
Vancomycin HCl Oral Solution
CGMP Deviations
Class II · Moderate risk
Tetracaine HCl Nasal Solution
CGMP Deviations
Class II · Moderate risk
Promethazine HCl Topical Ointment
CGMP Deviations
Class II · Moderate risk
Vitamin K (Vitamin K)
CGMP Deviations
Class II · Moderate risk
Lidocaine HCl/Phenylephrine HCl Nasal Solution
CGMP Deviations