Class II · Moderate risk
Atropine Sulfate Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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
DYNAMITE SUPER capsule
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Class I · High risk
NUX Male Enhancement capsule
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Class I · High risk
Pro Power Knight Plus capsule
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Class II · Moderate risk
Calcitonin Salmon
Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.
Class III · Low risk
Gabapentin Tablets
Product mixup: one foreign tablet found in product.
Class I · High risk
G-Supress DX
Product mix-up: incorrect product was found inside the G-Supress DX product carton.
Class III · Low risk
Lidocaine Patch 5%
Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each tablet contains instead of each adhesive patch contains.
Class II · Moderate risk
Fyremadel (ganirelix acetate)
Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.
Class II · Moderate risk
Seatex Alcohol Antiseptic 80% Topical Solution Hand Sanitizer…
Superpotent Drug and Failed Impurities/Degradation Products: formula does not adhere to the labeled specifications
Class III · Low risk
Avicel DG
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class III · Low risk
Avicel PH-200 NF
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class III · Low risk
Avicel PH-102 NF
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class III · Low risk
Avicel PH-101 NF
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class II · Moderate risk
C-Semaglutide 5mg/mL injection
Lack of assurance of sterility.
Class II · Moderate risk
Admelog
Lack of Assurance of Sterility: Malformed crimped collar seal
Class III · Low risk
Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL
Subpotent Drug: Out of specification results for low potency was obtained.
Class II · Moderate risk
Pantoprazole sodium for Injection 40 mg*/vial
CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures.
Class II · Moderate risk
Simvastatin USP 40 mg
CGMP deviations.
Class II · Moderate risk
Simvastatin USP 20 mg
CGMP deviations.
Class II · Moderate risk
Glimepiride USP
CGMP deviations.
Class II · Moderate risk
Simvastatin USP
CGMP deviations.
Class II · Moderate risk
Montelukast Sodium USP
CGMP deviations.
Class II · Moderate risk
Fast Acting Earwax Removal System
CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation.
Class II · Moderate risk
Advil Liqui-Gels Solubilized Ibuprofen Capsules
CGMP deviation: product outside labeled storage temperature requirements.