Class II · Moderate risk
Atropine Sulfate Injection
Presence of Particulate Matter: Particulate matter identified as fiber.
FDA drug recalls in 2023
Every FDA drug recall initiated in 2023, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,122 recalls, newest first.
Class I · High risk
Albuterol Sulfate Inhalation Aerosol
Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).
Class III · Low risk
Amlodipine Besylate Tablets
Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
Class II · Moderate risk
Losartan Potassium Tablets
Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.
Class II · Moderate risk
Tizanidine Hydrochloride Tablet 4mg
Failed Stability Specifications
Class I · High risk
Tydemy
Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test
Class II · Moderate risk
Safe Tussin PM Night Time Cough Relief
CGMP Deviations: use of non-food grade lubricant in mixing vessel.
Class II · Moderate risk
Safe Tussin DM Cough + Chest Congestion
CGMP Deviations: use of non-food grade lubricant in mixing vessel.
Class III · Low risk
PANCREAZE (pancrelipase)
Failed Stability Specifications
Class II · Moderate risk
Tizanidine Tablets
Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of specification results for dissolution.
Class II · Moderate risk
Diclofenac Sodium Topical Solution USP
Defective Delivery System
Class II · Moderate risk
Tizanidine Tablets USP
Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.
Class II · Moderate risk
Tramadol Hydrochloride Tablets
Packaging defect: blister packaging inadequately sealed.
Class II · Moderate risk
Dry Eye Relief Lubricant Eye Drops
CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
Class II · Moderate risk
Original Eye Drops
CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
Class III · Low risk
Tranexamic Acid USP Tablets
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class II · Moderate risk
Endometrin
cGMP deviations: potential for Microbial Contamination of Non-Sterile Products
Class III · Low risk
Lysteda (tranexamic acid)
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class III · Low risk
Glycopyrrolate Injection
Labeling: Label Mix-up
Class II · Moderate risk
StellaLife VEGA Oral Care Gel
cGMP deviations
Class II · Moderate risk
StellaLife VEGA Oral Care Gel
cGMP deviations
Class II · Moderate risk
StellaLife VEGA Oral Care Spray
cGMP deviations
Class II · Moderate risk
StellaLife VEGA Oral Care Rinse
cGMP deviations
Class II · Moderate risk
StellaLife VEGA Oral Care Rinse
cGMP deviations
Class II · Moderate risk
SnoreStop Naso Spray Bulk
cGMP deviations