Class II · Moderate risk
Benzefoam Emollient Foam Benzoyl Peroxide 5.3% 100gm Top Emol NDC 187-0194--10
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
FDA drug recalls in 2021
Every FDA drug recall initiated in 2021, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,152 recalls, newest first.
Class II · Moderate risk
Lotemax Sm
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Nuedexta (dextromethorphan HBr and quinidine sulfate)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Eszopiclone 3mg 100 C4
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Ondansetron HCL 4mg 30
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Amoxicillin 500mg 100
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Eletriptan Hydrobromide Tablets 20 mg* 6
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Ibuprofen Oral Suspension USP 100mg/5ml 120ml
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
xigduo XR (dapagliflozin/metformin HCl extended-release)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
xigduo XR (dapgliflozin/metformin HCl extended-release)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Bevespi Aerosphere
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Brilinta ticagrelar tablets 60 mg 60 tablets Rx only NDC…
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Gemcitabine Injection 200mg/5.26ml
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40…
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40…
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Edarbi (azilsartan medoxomil)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Timolol Maleate Ophthalmic Solution
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Butorphanol Tartrate Nasal Solution USP 10 mg/mL 2. 5 mL bottles…
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Enoxaparin Dofium Injrvyion
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Travoprost Ophthalmic Solution
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Erythromycin Tablets
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Oseltamivir Phosphate for Oral Suspension 6 mg/mL* *Each mL…
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Buprenorphine and Naloxone Sublingual Film 4mg/1mg 30 Pouches…
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Nitrofurantoin Macrocrystals Capsules 25 mg 100 Capsules Rx Only…
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Vraylar (cariprazine)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.