Class II · Moderate risk
Progesterone
Lack of Processing Controls (lack of assurance of conformity to specifications).
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
Minoxidil/Biotin/Spironolactone 1.25/5/25mg capsules
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Minoxidil/Biotin 1.25mg/5mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Formula 82M
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Formula 82F
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Finasteride Plus 1.25mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Estriol 8 mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Estriol 6 mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
D-Biotin 300 mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Calcium citrate tetrahydrate USP powder
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Lidothol Patch
CGMP Deviations: Contract Manufacturing Organization (CMO) misplaced/lost batch records and test results for the recalled batch.
Class III · Low risk
Tecfidera (dimethyl fumarate)
cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.
Class II · Moderate risk
Acetaminophen and Codeine Phosphate 300/30 mg tablet
cGMP Deviations
Class II · Moderate risk
Levothyroxin
Lack of Processing Control
Class II · Moderate risk
Betahistine 16 mg Capsule 180 capsules bottle
Lack of Processing Control
Class II · Moderate risk
Ergotamine Tartrate 1 mg/Caffeine 100 mg base F Suppository
Lack of Processing Control
Class II · Moderate risk
Tretinoin 0.1% in Versabase Cream 0.1% Versabase CR 45 gm jar
Lack of Processing Control
Class II · Moderate risk
Testosterone w/Cosmetic HRT Base 20 mg
Lack of Processing Control
Class II · Moderate risk
Ketoprofen/DMSO 20%/10% Lipoderm 50 gm jar
Lack of Processing Control
Class II · Moderate risk
Testosterone in Atrevis 75 mg/mL Gel 90 GMS tube
Lack of Processing Control
Class II · Moderate risk
Progesterone/Natacream 20 mg/2% mL Cream 60 gm jar
Lack of Processing Control
Class II · Moderate risk
Paregoric Alternate Elixir 300 mL bottle
Lack of Processing Control
Class II · Moderate risk
Estriol/Testosterone Vaginal 0.1/0.1% Cream 30 gm jar
Lack of Processing Control
Class II · Moderate risk
Bi-Est (8:2)
Lack of Processing Control
Class II · Moderate risk
Bi-Est (1:1)
Lack of Processing Control
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