Class I · High risk
Docusate Oral 10 mg/mL Oral Syringe
Microbial Contamination of Non-Sterile Products; microbial contamination with B. cepacia
FDA Drug Recalls
1,103 recalls, newest first
Class I · High risk
Cetylev (acetylcysteine)
Defective Container: Incomplete seal on blister packaging, leading to tablet swelling and enlarging due to effervescence process beginning as oxygen and moisture enter the blister packaging.
Class II · Moderate risk
Sermorelin 6 mg and Sermorelin 6 mg/GHRP-2 Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Human Chorionic Gonadotropin Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Venlafaxine HCL ER Capsule USP
Failed Dissolution Specifications: out of specification dissolution results in retained samples
Class II · Moderate risk
Venlafaxine HCL ER Capsule USP
Failed Dissolution Specifications: out of specification dissolution results in retained samples
Class II · Moderate risk
Bactroban Ointment
Penicillin Cross Contamination
Class II · Moderate risk
Bactroban Nasal
Penicillin Cross Contamination
Class II · Moderate risk
Bactroban Cream
Penicillin Cross Contamination
Class II · Moderate risk
Bactroban Cream
Penicillin Cross Contamination
Class III · Low risk
Children's Qnasl 40 mcg
Failed Content Uniformity Specifications: out of specification test result for spray content uniformity.
Class I · High risk
Diocto Liquid
Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia
Class II · Moderate risk
Trokendi XR
Superpotent Drug: Failure of assay specifications in the capsule.
Class II · Moderate risk
Dextroamphetamine Sulfate Extended-Release Capsules
Failed Dissolution Specifications
Class II · Moderate risk
Acetylcyst 10% OPHT SOL
Lack of Assurance of Sterility: Sterile products were not produced in a controlled, sterile environment.
Class II · Moderate risk
Metronidazole 500mg Tablet
CGMP Deviations
Class II · Moderate risk
Doxycycline100mg Tablets
CGMP Deviations
Class II · Moderate risk
Acyclovir 400mg Tablet
CGMP Deviations
Class II · Moderate risk
Class II · Moderate risk
Atorvastatin Calcium 40mg Tablet
CGMP Deviations
Class II · Moderate risk
Acetaminophen 325mg tablets
CGMP Deviations
Class II · Moderate risk
Oxygen Nasal Wash
Marketed Without An Approved NDA/ANDA: product is an unapproved drug due to nasal decongestant claims as well as not complying with the nasal decongestant final monograph.
Class II · Moderate risk
Dream Body Advanced 400 mg 30 capsules in brown foil packets.
Marketed without an approved NDA/ANDA: Undeclared sibutramine.
Class II · Moderate risk
Dream Body 450 mg 30 capsules in a plastic screw on top bottle
Marketed without an approved NDA/ANDA: Undeclared sibutramine.
Class II · Moderate risk
Dream Body Extreme Gold 800 mg 30 capsules in a plastic screw on…
Marketed without an approved NDA/ANDA: Undeclared sibutramine.