Class II · Moderate risk
Opdualag (nivolumab and relatlimab-rmbw)
Lack of Assurance of Sterility.
FDA drug recalls in 2025
Every FDA drug recall initiated in 2025, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
778 recalls, newest first.
Class I · High risk
SILINTAN 25/pills
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.
Class II · Moderate risk
NIACIN Extended-Release Tablets
Failed Dissolution Specifications
Class III · Low risk
Klarity-C Drops
Subpotent Drug
Class II · Moderate risk
Acetaminophen 500mg Caffeine 65mg caplets
Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg.
Class II · Moderate risk
Prazosin Hydrochloride
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Class II · Moderate risk
Prazosin Hydrochloride
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Class II · Moderate risk
Prazosin Hydrochloride
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Class II · Moderate risk
Tirzepatide Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Testosterone / Triamcinolone Acetonide Pellet
CGMP Deviations: Potential presence of metal particulate matter
Class II · Moderate risk
Testosterone / Triamcinolone Acetonide Pellet
CGMP Deviations: Potential presence of metal particulate matter
Class II · Moderate risk
Testosterone / Triamcinolone Acetonide 87.5MG/17.5MCG
CGMP Deviations: Potential presence of metal particulate matter
Class II · Moderate risk
Testosterone / Triamcinolone Acetonide
CGMP Deviations: Potential presence of metal particulate matter
Class II · Moderate risk
Testosterone / Triamcinolone Acetonide 50MG/10MCG
CGMP Deviations: Potential presence of metal particulate matter
Class II · Moderate risk
Testosterone / Triamcinolone Acetonide Pellet
CGMP Deviations: Potential presence of metal particulate matter
Class II · Moderate risk
Testosterone / Triamcinolone Acetonide 25MG/5MCG
CGMP Deviations: Potential presence of metal particulate matter
Class II · Moderate risk
Testosterone / Triamcinolone Acetonide
CGMP Deviations: Potential presence of metal particulate matter
Class II · Moderate risk
Testosterone Regular Release 200 MG
CGMP Deviations: Potential presence of metal particulate matter
Class II · Moderate risk
Testosterone Regular Release 50 MG
CGMP Deviations: Potential presence of metal particulate matter