Class II · Moderate risk
Alprazolam C-IV
CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
FDA Drug Recalls
316 recalls, newest first
Class II · Moderate risk
Alprazolam C-IV
CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Class II · Moderate risk
Alprazolam C-IV
CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Class II · Moderate risk
Aripiprazole Tablets
Out of specification (OOS) for Spectroscopic Identification test by IR.
Class II · Moderate risk
Tadalafil Tablets
CGMP Deviations
Class II · Moderate risk
Tadalafil Tablets
CGMP Deviations
Class II · Moderate risk
Glimepiride Tablets
CGMP Deviations
Class II · Moderate risk
Glimepiride Tablets
CGMP Deviations
Class II · Moderate risk
Doxazosin Tablets
CGMP Deviations
Class II · Moderate risk
BusPIRone Hydrochloride Tablets USP
CGMP Deviations
Class II · Moderate risk
Atorvastatin Calcium Tablets
CGMP Deviations
Class III · Low risk
Epinephrine Professional EMS
Labeling; Incorrect NDC number on outer carton of product.
Class II · Moderate risk
Dabigatran Etexilate 150mg Capsules
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Class II · Moderate risk
Dabigatran Etexilate Capsules
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Class II · Moderate risk
Pantoprazole Sodium Delayed Release Tablets USP 40mg
CGMP Deviations: Discoloration
Class I · High risk
Atovaquone Oral Suspension USP
Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for shear.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for shear.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for shear.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for shear.
Class III · Low risk
MEKTOVI (binimetinib)
Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry date of March 2026; the correct expiration date is February 2025.
Class I · High risk
Delsam Pharma's Artificial Eye Ointment
Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.
Class II · Moderate risk
NaturalCare
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Class II · Moderate risk
NaturalCare bioAllers
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Class II · Moderate risk
NatraBio
CGMP Deviations: Raw material recalled by repackager, due to discoloration.