Class II · Moderate risk
Oxygen
CGMP Deviations
Manufacturing (cGMP) deviations
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards.
1,754 FDA drug recalls with this cause, newest first.
This category covers departures from current Good Manufacturing Practice during production. It is FDA's broadest label, used when a facility's own process control failed somewhere along the line even if no single ingredient was proven unsafe on its own. Where the report names a specific consequence - a temperature excursion, a contaminant, a potency problem - we file the recall under that more specific cause instead; what remains here is the genuinely general case.
Class II · Moderate risk
Cidofovir Dihydrate
CGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Class II · Moderate risk
Domperidone 10 mg capsules
Lack of Processing Controls.
Class II · Moderate risk
Progesterone 100 mg SR capsules
Lack of Processing Controls.
Class II · Moderate risk
Promethazine Gel 50 mg/mL
Lack of Processing Controls.
Class II · Moderate risk
Testosterone 0.1% cream
Lack of Processing Controls.
Class II · Moderate risk
Progesterone 10% cream
Lack of Processing Controls.
Class II · Moderate risk
Omeprazole 4 mg/mL Suspension
Lack of Processing Controls.
Class II · Moderate risk
FastStat Topical Hemostat Introductory Kit
cGMP violations noted during the firm's most recent inspection.
Class II · Moderate risk
BeeGentle Honey Flavored Topical Anesthetic
cGMP violations noted during the firm's most recent inspection.
Class II · Moderate risk
SHEER DesenZ Desensitizing Treatment
cGMP violations noted during the firm's most recent inspection.
Class II · Moderate risk
fas.TRACT Coagulative Hemostatic Gel
cGMP violations noted during the firm's most recent inspection.
Class II · Moderate risk
Prevacid 24HR
CGMP deviations
Class II · Moderate risk
Glipizide XL
CGMP Deviations; rejected product was used to manufacture final bulk lot
Class II · Moderate risk
Class II · Moderate risk
NeoRelief for Muscle Cramping & Restlessness Homeopathic Topical Gel
CGMP Deviations: finished product produced with active ingredients recalled by the manufacturer, King Bio Inc., due to water contamination issues that could potentially affect the quality of this product.
Class II · Moderate risk
Thyroid powder
CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Class II · Moderate risk
Thyroid
CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Class II · Moderate risk
Thyroid
CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Class II · Moderate risk
Thyroid
CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Class II · Moderate risk
Thyroid Powder
CGMP Deviations: Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Class II · Moderate risk
Thyroid Powder USP
CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Class II · Moderate risk
Thyroid Powder USP
CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Class II · Moderate risk
0.9% Sodium Chloride Injection USP 100 mL bags
CGMP Deviations
Class II · Moderate risk
Thyroid Powder 25kg/drum
CGMP Deviations: Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
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.