Class II · Moderate risk
Profound-PE Dental Gel
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
Profound-PE Dental Gel
CGMP Deviations
Class II · Moderate risk
Profound Dental Gel
CGMP Deviations
Class II · Moderate risk
Profound Dental Gel
CGMP Deviations
Class II · Moderate risk
Lidocaine HCl / Oxymetazoline HCl Nasal Solution
CGMP Deviations
Class II · Moderate risk
LET Topical Gel
CGMP Deviations
Class II · Moderate risk
LT Topical Cream
CGMP Deviations
Class II · Moderate risk
Dibutyl Squaric Acid
CGMP Deviations
Class II · Moderate risk
Dibutyl Squaric Acid
CGMP Deviations
Class II · Moderate risk
Dexamethasone sodium phosphate 0.4%
CGMP Deviations
Class II · Moderate risk
CSF-HC Otic Insufflation Capsule
CGMP Deviations
Class II · Moderate risk
CSF Otic Insufflation Capsule
CGMP Deviations
Class II · Moderate risk
Cantharidin PLUS
CGMP Deviations
Class II · Moderate risk
Cantharidin Gel-Forming Suspension
CGMP Deviations
Class II · Moderate risk
BLT Topical Cream
CGMP Deviations
Class II · Moderate risk
Extra Strength Headache
CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
Class II · Moderate risk
Medique Pain-Off
CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
Class II · Moderate risk
Physicians CARE Extra Strength PAIN RELIEVER
CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
Class II · Moderate risk
B-Complex
Lack of Processing Controls
Class II · Moderate risk
Methylcobalamin 12mg/ml injection
Lack of Processing Controls
Class II · Moderate risk
Acetaminophen Oral Suspension
cGMP Deviations: Product manufactured with contaminated raw ingredient.
Class II · Moderate risk
Acetaminophen Oral Suspension
cGMP Deviations: Product manufactured with contaminated raw ingredient.
Class II · Moderate risk
artnaturals Hand Sanitizer
CGMP Deviations: Other lots recalled because they were manufactured using common ingredients as the contaminated lot
Class II · Moderate risk
artnaturals hand sanitizer
CGMP Deviations: Other lots recalled because they were manufactured using common ingredients as the contaminated lot
Class II · Moderate risk
Maximum Strength Nasal Spray
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
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