Class II · Moderate risk Terminated
Minoxidil/Biotin/Spironolactone 1.25/5/25mg capsules
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Minoxidil/Biotin 1.25mg/5mg Capsule
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
Formula 82M
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
Formula 82F
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
Finasteride Plus 1.25mg Capsule
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
Estriol 8 mg Capsule
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
Estriol 6 mg Capsule
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
D-Biotin 300 mg Capsule
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
Calcium citrate tetrahydrate USP powder
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
Cefdinir for Oral Suspension USP
Reason Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.
Class II · Moderate risk Terminated
Lidothol Patch
Reason CGMP Deviations: Contract Manufacturing Organization (CMO) misplaced/lost batch records and test results for the recalled batch.
Class II · Moderate risk Terminated
Carbamazepine 200 mg Tablets
Reason FAILED DISSOLUTION SPECIFICATION: Low out-of-specification (OOS) dissolution results obtained during routine stability testing.
Class II · Moderate risk Terminated
Cetrotide
Reason Defective Container: Market complaints of missing rubber stoppers from drug vial. Missing rubber stoppers could lead to lack of sterility assurance.
Class II · Moderate risk Terminated
Saniderm ADVANCED HAND SANITIZER
Reason CGMP Deviations: Product was found to be below the label claim for ethanol content and the presence of undeclared methanol.
Class II · Moderate risk Terminated
Metformin HCl Extended Release Tablets
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Class II · Moderate risk Terminated
Childrens Dimetapp Cold & Cough
Reason Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.
Class II · Moderate risk Terminated
Childrens Robitussin Honey Cough and Chest Congestion DM
Reason Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.
Class II · Moderate risk Terminated
Heparin Sodium 5
Reason Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
Class II · Moderate risk Terminated
Tropical Lip Moisturizer
Reason Superpotent Drug: The beginning portion of the batch appears to be approximately 25% superpotent for active ingredient Meradimate.
Class II · Moderate risk Terminated
Clozapine Tablets USP tablet
Reason Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg.
Class II · Moderate risk Terminated
Metformin Hydrochloride Extended-Release Tablets
Reason CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels.
Class II · Moderate risk Terminated
Koala Hand Sanitizer
Reason Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.
Class II · Moderate risk Terminated
Koala Hand Sanitizer
Reason Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.
Class II · Moderate risk Terminated
Koala Hand Sanitizer
Reason Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.
Class II · Moderate risk Terminated
Metformin Hydrochloride Extended-release Tablets USP
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level