Class II · Moderate risk
HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
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 II · Moderate risk
HYDROmorphone HCl 20 mg/100mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL 2
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL 1
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL 500 mcg/100 mL
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL 500 mcg/100 mL
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL 100 mcg/50 mL
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL 200 mcg/100 mL
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL 200 mcg/100 mL
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL 2
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL 2
Lack of Assurance of Sterility
Class II · Moderate risk
Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class III · Low risk
LET Gel
Product Mix-up: Incorrect Product Formulation
Class II · Moderate risk
Oxygen
cGMP Deviations
Class I · High risk
Dr. Ergin's SugarMD
MARKETED WITHOUT AN APPROVED NDA/ANDA: Product found to be tainted with metformin and glyburide
Class II · Moderate risk
Naproxen Tablets
Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
Class II · Moderate risk
Indomethacin 25mg Capsules
Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
Class I · High risk
VITRAKVI (larotractenib)
Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing
Class III · Low risk
Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP
Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
Class II · Moderate risk
Trospium Chloride Extended-Release Capsules
Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules
Class II · Moderate risk
Paroxetine Hydrochloride Tablets USP
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Class II · Moderate risk
Paroxetine Hydrochloride Tablets USP
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Class II · Moderate risk
Paroxetine Hydrochloride Tablets USP
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Class II · Moderate risk
Paroxetine Hydrochloride Tablets USP
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Class I · High risk
LEADER brand Lubricant Eye Drops
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.