Class II · Moderate risk
Autologous Serum Tears
Lack of Assurance of Sterility
FDA drug recalls in 2016
Every FDA drug recall initiated in 2016, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,199 recalls, newest first.
Class II · Moderate risk
Methylcobalamin 5
Lack of Assurance of Sterility
Class II · Moderate risk
Morphine Sulfate 15mg/ml Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Moxifloxacin HCl 1 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Brilliant Blue G
Lack of Assurance of Sterility
Class II · Moderate risk
Trypan Blue 0.3%
Lack of Assurance of Sterility
Class II · Moderate risk
Papaverine 150 mg/Phentolamine 5 mg and Prostaglandin 50 mcg
Lack of Assurance of Sterility
Class II · Moderate risk
Papaverine 150 mg / Phentolamine 5 mg vials
Lack of Assurance of Sterility
Class II · Moderate risk
Moxi/Dex/Ketorolac 0.5%/0.1%/0.4%
Lack of Assurance of Sterility
Class II · Moderate risk
Moxifloxacin 0.5% + Dexamethazone 0.1%
Lack of Assurance of Sterility
Class II · Moderate risk
Apomorphine HCl 3mg/ml Sterile Injection Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Buprenorphine
Lack of Assurance of Sterility
Class II · Moderate risk
Chlorpheniramine Maleate 10 mg/ml
Lack of Assurance of Sterility
Class I · High risk
Docusate Oral 10 mg/mL Oral Syringe
Microbial Contamination of Non-Sterile Products; microbial contamination with B. cepacia
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