Class II · Moderate risk Ongoing
Doxazosin Tablets
Reason CGMP Deviations
FDA Drug Recalls
2,277 recalls · Class II, newest first
Class II · Moderate risk Ongoing
BusPIRone Hydrochloride Tablets USP
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Atorvastatin Calcium Tablets
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Dabigatran Etexilate 150mg Capsules
Reason CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Class II · Moderate risk Ongoing
Dabigatran Etexilate Capsules
Reason CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Class II · Moderate risk Ongoing
Pantoprazole Sodium Delayed Release Tablets USP 40mg
Reason CGMP Deviations: Discoloration
Class II · Moderate risk Ongoing
Daytrana
Reason Defective Delivery System: Out of specification for shear.
Class II · Moderate risk Ongoing
Daytrana
Reason Defective Delivery System: Out of specification for shear.
Class II · Moderate risk Ongoing
Daytrana
Reason Defective Delivery System: Out of specification for shear.
Class II · Moderate risk Ongoing
Daytrana
Reason Defective Delivery System: Out of specification for shear.
Class II · Moderate risk Ongoing
NaturalCare
Reason CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Class II · Moderate risk Ongoing
NaturalCare bioAllers
Reason CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Class II · Moderate risk Ongoing
NatraBio
Reason CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Class II · Moderate risk Ongoing
NaturalCare bioAllers
Reason CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Class II · Moderate risk Ongoing
Purely Soothing MSM Nasal Spray
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Fentanyl 500mcg
Reason Lack of assurance of sterility: Suspected microbial growth present on external label packaging.
Class II · Moderate risk Ongoing
Tacrolimus Capsules
Reason Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules.
Class II · Moderate risk Ongoing
Delsam Pharma's ARTIFICIAL TEARS
Reason CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.
Class II · Moderate risk Ongoing
Artificial Tears
Reason CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.
Class II · Moderate risk Ongoing
Hand Sanitizer
Reason CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary approval, into the market after March 31, 2022.
Class II · Moderate risk Ongoing
Hand Sanitizer
Reason CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary approval, into the market after March 31, 2022.
Class II · Moderate risk Ongoing
Humatrix Microclysmic Gel
Reason CGMP Deviations: initiated due to violations of CGMP manufacturing practices
Class II · Moderate risk Ongoing
Techni-Care Chloroxylenold 3%
Reason CGMP Deviations: initiated due to violations of CGMP manufacturing practices
Class II · Moderate risk Ongoing
Acyclovir Sodium Injection 1
Reason Presence of Particulate Matter: Customer complaint of dark particles found inside the vial
Class II · Moderate risk Ongoing
Glycopyrrolate Tablets
Reason Failed Impurities/Degradation Specifications