Class II · Moderate risk
Thyroid 1 Grain Tablets
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
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
Hydrochlorothiazide 50mg tablets
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class II · Moderate risk
Hydrochlorothiazide
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class II · Moderate risk
Hydrochlorothiazide 25mg tablets
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class II · Moderate risk
VILEVEV MB Urinary Antispetic
cGMP deviations
Class II · Moderate risk
Vilamit Mb
cGMP deviations
Class II · Moderate risk
Bersih Hand Sanitizer Gel
cGMP Deviations
Class II · Moderate risk
Auryxia (ferric citrate)
cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia.
Class II · Moderate risk
bio aaa Advance Hand Sanitizer Ethyl Alcohol 70%
CGMP Deviations
Class II · Moderate risk
Yohimbine HCL 5.4mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Vardenafil 20 mg Troche
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Testosterone/Anastrozole Pellet 100/6 mg
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Tadalafil 7 mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Tadalafil 3 mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Tadalafil 26 mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Tadalafil 18 mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Tadalafil 12 mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Sildenafil 50 mg Troche
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Progesterone Modified Release 200 mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Progesterone Modified Release 100 mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Progesterone 50 mg Modified Release Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Progesterone 200 mg Troche
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Progesterone
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Progesterone 300 mg Troche
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Progesterone 150 mg Troche
Lack of Processing Controls (lack of assurance of conformity to specifications).
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