Class II · Moderate risk
Bevespi Aerosphere
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Temperature excursions
The product was stored or shipped outside its labeled temperature range. Heat or freezing can degrade a drug without any visible change, so it may be weaker than labeled.
569 FDA drug recalls with this cause, newest first.
Vaccines, insulin, many injectables and some tablets must stay within a narrow temperature band from factory to pharmacy. A truck without working refrigeration, a freezer failure or a warehouse heatwave is enough: the product looks normal but may have lost potency or formed degradation products. FDA files these under 'CGMP deviations' or 'temperature abuse'; we track them separately because the question to ask - how was my medication stored? - is different from every other cause.
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.
Class II · Moderate risk
Rectiv (nitroglycerin)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Namzaric (memantine HCl extended release and donepezil HCl)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Linzess (linaclotide)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Restasis 0.05%30x 0.4ml Opth Pf
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Ubrelvy 100mg 10ud Cplt
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Vaniqa (eflornithine hydrochloride)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Bromfenac Ophthalmic Solution 0.09% 1.7ml Ndc/Upc 62332-508-17
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Metoprolol Tartrate and Hydrochlorothiazide Tablets
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
COSOPT (Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Atropine Sulfate Ophthalmic Solution
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.