Class II · Moderate risk
Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1
Subpotent Drug: Out of specification for assay
FDA drug recalls in 2024
Every FDA drug recall initiated in 2024, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
557 recalls, newest first.
Class I · High risk
To the Moon Capsules
Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
Class I · High risk
Ram It
Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
Class I · High risk
TING 1% Tolnaftate Athlete's Foot Spray Antifungal Spray Liquid
Chemical Contamination; presence of benzene.
Class III · Low risk
HydrALAZINE Hydrochloride Tablets
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.
Class II · Moderate risk
Lansoprazole Delayed-Release Capsules USP
CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were missing on one bottle.
Class II · Moderate risk
Lubricant PM Ointment
Lack of Assurance of Sterility
Class II · Moderate risk
CVS Health Lubricant Eye Ointment
Lack of Assurance of Sterility
Class II · Moderate risk
Equate Stye Lubricant Eye Ointment
Lack of Assurance of Sterility
Class II · Moderate risk
Equate Lubricant Eye Ointment
Lack of Assurance of Sterility
Class II · Moderate risk
Pure Care Foaming Mint Hand Sanitizer 62%
CGMP Deviations
Class III · Low risk
Nortrel 7/7/7
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Class III · Low risk
Nortrel (norethindrone and ethinyl estradiol tablets USP)
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Class II · Moderate risk
Febuxostat Tablets
CGMP Deviations
Class II · Moderate risk
Norepinephrine Bitartrate in 5% Dextrose Injection
Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the primary bag label correctly identified the product strength as 8 mg / 250 mL.
Class II · Moderate risk
Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection
Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date.
Class II · Moderate risk
Equate Cherry Cough Drops
CGMP Deviations: Potential Glass and Silicone particulates in product
Class II · Moderate risk
Family Wellness Cherry Cough Drops Menthol cough suppressant/Oral Anesthetic
CGMP Deviations: Potential Glass and Silicone particulates in product
Class II · Moderate risk
Kroger Cherry Cough Drops
CGMP Deviations: Potential Glass and Silicone particulates in product
Class II · Moderate risk
Meijer Cherry Cough Drops
CGMP Deviations: Potential Glass and Silicone particulates in product
Class II · Moderate risk
CVS Health Cherry Cough Drops
CGMP Deviations: Potential Glass and Silicone particulates in product
Class II · Moderate risk
Omeza Skin Protectant
CGMP Deviations
Class II · Moderate risk
Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS
CGMP Deviations
Class III · Low risk
Glimepiride Tablets
Misprint on tablet
Class III · Low risk
Glimepiride Tablets
Misprint on tablet