Class II · Moderate risk
Acetylcysteine Ophthalmic 10% Solution
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
Desmopressin Acetate Tablets
GMP Deviations: Product bottle may be absent of desiccant.
Class II · Moderate risk
Desmopressin Acetate Tablets
GMP Deviations: Product bottle may be absent of desiccant.
Class II · Moderate risk
Ethacrynate Sodium for Injection
cGMP Deviations
Class II · Moderate risk
Methylphenidate hydrochloride Extended-Release ablets USP
CGMP deviations: Product bottle may be absent of desiccant.
Class II · Moderate risk
Methylphenidate hydrochloride Extended-Release ablets USP
CGMP deviations: Product bottle may be absent of desiccant.
Class II · Moderate risk
Desmopressin Acetate Tablets
GMP Deviations: Product bottle may be absent of desiccant.
Class II · Moderate risk
Desmopressin Acetate Tablets
GMP Deviations: Product bottle may be absent of desiccant.
Class II · Moderate risk
Solifenacin Succinate Tablets
CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.
Class II · Moderate risk
Solifenacin Succinate Tablets
CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.
Class II · Moderate risk
Olmesartan Medoxomil Tablets 20 mg
cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement.
Class II · Moderate risk
Yeast Arrest
cGMP violations
Class II · Moderate risk
Albuterol 2.5mg / Ipratropium 0.75mg/ Triamcinolone 0.5 mg 3ML Vial
Lack of Processing Controls
Class II · Moderate risk
Albuterol 1.25mg / Ipratropium 0.5mg
Lack of Processing Controls
Class II · Moderate risk
Albuterol 1.25mg / Ipratropium 0.5mg/ Budesonide 0.25mg
Lack of Processing Controls
Class II · Moderate risk
Albuterol 2.5mg / Budesonide 0.5mg
Lack of Processing Controls
Class II · Moderate risk
Albuterol 2.5mg / Ipratropium 0.75mg /Budesonide 0.25mg
Lack of Processing Controls
Class II · Moderate risk
Albuterol 2.5mg / Ipratropium 0.75mg /Budesonide 0.5mg
Lack of Processing Controls
Class II · Moderate risk
Albuterol 2.5mg / Ipratropium 0.75mg
Lack of Processing Controls
Class II · Moderate risk
Albuterol 3.75mg / Ipratropium 0.75mg
Lack of Processing Controls
Class II · Moderate risk
Budesonide 0.4mg
Lack of Processing Controls
Class II · Moderate risk
Formoterol 12mcg / Budesonide 0.5mg
Lack of Processing Controls
Class II · Moderate risk
R2103
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk
StellaLife VEGA Oral Gel Rinse
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk
Pareira (Brava)
CGMP Deviations: products were not manufactured under current good manufacturing practices.
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.