Class II · Moderate risk
Broadway Joe's Pain Cream
CGMP Deviations: Potential contamination of raw material
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.
- Total recalls
- 1,754
- Class I (high risk)
- 3
- Currently ongoing
- 381
- Most recent
- Aug 21, 2026
Most-cited firms for this cause
- Reliable Rexall-A Compounding Pharmacy69
- Kroger Specialty Pharmacy, Inc.67
- Accord Healthcare, Inc.67
- Ultra Seal Corporation56
- Glenmark Pharmaceuticals Inc., USA56
- The Medicine Shoppe Pharmacy54
- Perrigo Company PLC51
- Product Quest Manufacturing LLC43
Class II · Moderate risk
Broadway Joe's Pain Cream
CGMP Deviations: Potential contamination of raw material
Class II · Moderate risk
Menow Sunscreen Pressed Powder Spf35 PA+++
cGMP Deviations
Class II · Moderate risk
Carbamazepine Tablets
CGMP deviations: tablets with black specks.
Class II · Moderate risk
Daptomycin
CGMP Deviations
Class II · Moderate risk
Vancomycin Injection
CGMP Deviations
Class II · Moderate risk
Vasopressin
CGMP Deviations
Class II · Moderate risk
Clindamycin Injection USP in 5% Dextrose
CGMP Deviations
Class II · Moderate risk
Clindamycin Injection USP in 5% Dextrose
CGMP Deviations
Class II · Moderate risk
Clindamycin Phosphate in 0.9% Sodium Chloride Injection
CGMP Deviations
Class II · Moderate risk
Clindamycin Injection USP in 5% Dextrose
CGMP Deviations
Class II · Moderate risk
Nexterone (amiodarone HCI)
CGMP Deviations
Class II · Moderate risk
Cardene IV
CGMP Deviations
Class II · Moderate risk
Pantoprazole Sodium in 0.9% Sodium Chloride Injection
CGMP Deviations
Class II · Moderate risk
Vasopressin
CGMP Deviations
Class II · Moderate risk
Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection
CGMP Deviations
Class II · Moderate risk
Famotidine Injection in Sodium Chloride Injection
CGMP Deviations
Class II · Moderate risk
Clindamycin Injection USP in 5% Dextrose
CGMP Deviations
Class II · Moderate risk
Daptomycin
CGMP Deviations
Class II · Moderate risk
Myxredlin
CGMP Deviations
Class II · Moderate risk
Vancomycin Injection
CGMP Deviations
Class II · Moderate risk
Carbamazepine Tablets
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
Class II · Moderate risk
Sildenafil Citrate USP
CGMP Deviations:Noted during FDA inspection
Class II · Moderate risk
Tadalafil USP
CGMP Deviations:Noted during FDA inspection
Class II · Moderate risk
Tadalafil USP
CGMP Deviations:Noted during FDA inspection
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