Class II · Moderate risk Terminated
Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release…
Reason Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient
FDA Drug Recalls
14,801 recalls, newest first
Class II · Moderate risk Terminated
Moxifloxacin Ophthalmic Solution
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Metoprolol Succinate Extended-Release Tablets
Reason Failed Dissolution Specifications.
Class II · Moderate risk Terminated
Lung Cleaner
Reason cGMP deviations
Class II · Moderate risk Terminated
8.4% Sodium Bicarbonate Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Tretinoin Capsules
Reason Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution.
Class III · Low risk Terminated
Mucus Relief D
Reason Subpotent drug
Class II · Moderate risk Terminated
Clobetasol Propionate Foam
Reason CGMP Deviations
Class III · Low risk Terminated
Mimvey
Reason Mislabeling
Class III · Low risk Terminated
Mimvey
Reason Mislabeling
Class II · Moderate risk Terminated
Clobazam Oral Suspension 2.5 mg/mL
Reason Failed Stability Specifications
Class I · High risk Terminated
Semglee
Reason Labeling: Missing Label: label missing from some Semglee prefilled pens.
Class II · Moderate risk Terminated
Sufentanil Citrate Injection
Reason Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.
Class III · Low risk Terminated
Leader
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
CVS Health
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Qc Quality Choice
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
equate
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Dr. Reddys
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Kroger
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Rite Aid Pharmacy
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Rugby
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Wal-Fex D
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Norepinephrine Bitartrate Injection USP 4 mg/4 mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Metoprolol Tartrate Tablets
Reason Complaint received of foreign matter (metal) embedded in tablet.