Class II · Moderate risk
Sensorcaine
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
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
Sensorcaine
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
Class III · Low risk
Allergy Relief D
Failed dissolution specifications
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Recalled lot was found to be out of specification for shear. Shear is an attribute related to the adhesive properties of the transdermal patches.
Class III · Low risk
Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads
Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.
Class III · Low risk
Phenytoin Sodium Injection
Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Class III · Low risk
Phenytoin Sodium Injection
Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Class II · Moderate risk
PF-Neostigmine Methylsulfate Injection
CGMP Deviations: Potential for cross contamination due to product carry over.
Class II · Moderate risk
PF-Labetalol HCl Injection
CGMP Deviations: Potential for cross contamination due to product carry over.
Class II · Moderate risk
Phenoxybenzamine Hydrochloride Capsules
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Conzerol zero molluscum contagiosum
CGMP deviations
Class III · Low risk
Triamterene and Hydrochlorothiazide Capsules
Failed Impurity/Degradation Specifications
Class III · Low risk
Triamterene and Hydrochlorothiazide Capsules
Failed Impurity/Degradation Specifications
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.
Class II · Moderate risk
Timolol-Latanoprost
Subpotent Drug: The batches contain less than 90% of the labeled amount of latanoprost.
Class II · Moderate risk
Adam's Polishes ALCOHOL BASED HAND SANITIZER
CGMP Deviations: Other lots of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
Class I · High risk
Adam's Polishes ALCOHOL BASED HAND SANITIZER
Chemical Contamination: FDA analysis found 1 lot of Adam's Polishes ALCOHOL BASED HAND SANITIZER isopropyl alcohol 75% v/v to contain methanol.
Class II · Moderate risk
Moxifloxacin Ophthalmic Solution
cGMP deviation: discontinue of stability support for product.
Class II · Moderate risk
Carvedilol Tablets
Failed Tablet/Capsule Specifications: Tablets exceeds specification for weight and thickness.
Class III · Low risk
Susvimo (ranibizumab injection)
Defective Delivery System: Commercial implants do not meet the filed specification for the intended use, a few patients have experienced an issue with the implants that renders it non-functioning.
Class II · Moderate risk
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg
Presence of Foreign Substance
Class II · Moderate risk
Tobramycin Ophthalmic Solution
CGMP Deviations:
Class II · Moderate risk
Tobramycin Ophthalmic Solution
CGMP Deviations:
Class II · Moderate risk
Timolol Maleate Ophthalmic Solution
CGMP Deviations: