Class II · Moderate risk
metformin HCL ER 500 mg
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
FDA drug recalls in 2020
Every FDA drug recall initiated in 2020, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
930 recalls, newest first.
Class III · Low risk
Desflurane
DEFECTIVE CONTAINER: Desflurane Liquid for Inhalation 240 mL may be leaking.
Class I · High risk
Class I · High risk
Hydromorphone Hcl-Bupivacaine Hcl-Sufentanil Pf…
Non-Sterility
Class I · High risk
Class I · High risk
Class I · High risk
Class I · High risk
Class I · High risk
Class I · High risk
MORPHINE-BUPIVACAINE PF INJECTABLE 21 mL
Non-Sterility
Class I · High risk
Class I · High risk
Class I · High risk
Class I · High risk
Fentanyl-Bupivacaine HCL Pf Injectable 3000mcg-12mg/Ml
Non-Sterility
Class I · High risk
Bupivacaine Hcl-Lioresal Pf Injectable 7.5mg-1625mcg/Ml
Non-Sterility
Class I · High risk
Bupivacaine Hcl-Baclofen Pf Injectable 40mg-4000mcg/Ml
Non-Sterility
Class II · Moderate risk
Catapres (clonidine hydrochloride, USP)
An extraneous peak was observed for dissolution testing.
Class II · Moderate risk
Catapres (clonidine hydrochloride, USP)
An extraneous peak was observed for dissolution testing.
Class II · Moderate risk
Catapres (clonidine hydrochloride, USP)
An extraneous peak was observed for dissolution testing.
Class II · Moderate risk
Time-Cap Labs
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
Time-Cap Labs
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
Chlorhexidine Gluconate 20% 0012 Medichem
Discoloration.
Class III · Low risk
Candesartan Cilexetil and Hydrochlorothiazide Tablets
Out-of-specification organic impurity results obtained during routine stability testing.
Class I · High risk
Smart Care HAND SANITIZER
Labeling: Not Elsewhere Classified. Container packaging is made, formed or filled to be misleading, resembling food and drink pouches
Class III · Low risk
Fluocinonide Ointment USP 0.05%
Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity.