Class II · Moderate risk
B-Complex 50 in Nacl 0.9% W/Pres.
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
B-Complex 50 in Nacl 0.9%
Lack of Assurance of Sterility
Class II · Moderate risk
B-Complex Without B12 W/Pres
Lack of Assurance of Sterility
Class II · Moderate risk
B-Complex Without B12
Lack of Assurance of Sterility
Class II · Moderate risk
B-COMPLEX (Lieberman)
Lack of Assurance of Sterility
Class II · Moderate risk
B-Complex #3 W/Pres
Lack of Assurance of Sterility
Class II · Moderate risk
B-Complex #3
Lack of Assurance of Sterility
Class III · Low risk
Hyoscyamine Sulfate Sublingual Tablets
Chemical Contamination: Bottles may contain broken dessicants
Class I · High risk
Super Samurai-X
Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
Class I · High risk
Ginseng Power-X
Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
Class I · High risk
Ninja-X
Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
Class I · High risk
Tiger-X
Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
Class II · Moderate risk
aloe SPORT liniment TOPICAL ANALGESIC 8 fl oz. tube
CGMP Deviations
Class II · Moderate risk
1% Clotrimazol cream
CGMP Deviations
Class II · Moderate risk
VERMOX Tablets 500 mg
CGMP Deviations
Class II · Moderate risk
VERMOX Tablets 100 mg
CGMP Deviations
Class II · Moderate risk
tabcin NOCHE
CGMP Deviations
Class II · Moderate risk
tabcin ACTIVE M.R. Capsules
CGMP Deviations
Class II · Moderate risk
Tazorac (tazarotene)
Failed Content Uniformity Specifications.
Class II · Moderate risk
Tazorac (tazarotene)
Failed Content Uniformity Specifications.
Class II · Moderate risk
Coppertone SUNSCREEN LOTION
Labeling; Product Contains Undeclared API (Oxybenzone)
Class II · Moderate risk
Bromocriptine Mesylate Capsules USP
Failed impurities/degradation specifications: Out of specification results noticed in related substance test during analysis of 24 months long term (25 degree Celsius /65% RH) stability samples of two batches.
Class II · Moderate risk
Vancomycin Hydrochloride for Injection
Presence of Particulate Matter: Cardboard
Class II · Moderate risk
8 mcg/mL HYDROmorphone HCl and 0.05% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
6.66 mcg/mL Fentanyl Citrate and 0.22% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.