Class II · Moderate risk
Otezla 30 mg tablet NDC 59572-0631-06 30 days supply
Lack of Processing Controls.
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
Pulmicort Respules 0.5 mg/2mL s
Lack of Processing Controls.
Class II · Moderate risk
Polyethylene Glycol 3350
Lack of Processing Controls.
Class II · Moderate risk
Pediasure Liq. Vanilla G+G
Lack of Processing Controls.
Class II · Moderate risk
Kalydeco 150 mg tablet blister
Lack of Processing Controls.
Class II · Moderate risk
Albuterol 0.083% Inh Sol. 30 days supply
Lack of Processing Controls.
Class II · Moderate risk
Humira Pen Sub-q Kit a.) 40 mg/0.8 mL
Lack of Processing Controls.
Class II · Moderate risk
WipeEssentials Wet Wipes
CGMP Deviations: finished products were manufactured with poor quality water.
Class II · Moderate risk
Acure
CGMP Deviations: finished products were manufactured with poor quality water.
Class II · Moderate risk
Zhong Hua Jiu
CGMP Deviations: the product was produced with substandard GMP manufacturing processes.
Class II · Moderate risk
Conzerol (antipoxin)
cGMP Deviations
Class II · Moderate risk
Molleave
cGMP Deviations
Class II · Moderate risk
Conzerol zero molluscum contagiosum
cGMP Deviations
Class III · Low risk
BonaDur For Men
CGMP Deviations: not manufactured according to current good manufacturing practices.
Class II · Moderate risk
Class II · Moderate risk
Aripiprazole Tablets
CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
Class II · Moderate risk
Ibuprofen Caplets USP 200 mg
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Class II · Moderate risk
Ibuprofen Caplets USP 200 mg
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Class II · Moderate risk
Ibuprofen Tablets USP 800 mg
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Class II · Moderate risk
Ibuprofen Tablets USP 800 mg
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Class II · Moderate risk
Ibuprofen Tablets USP 600 mg
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Class II · Moderate risk
Ibuprofen Tablets USP 600 mg
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Class II · Moderate risk
Ibuprofen Tablets USP 600 mg
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Class II · Moderate risk
Ibuprofen Tablets USP 400 mg
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Class II · Moderate risk
Ibuprofen Tablets USP 400 mg
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
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.