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
FDA Drug Recalls
14,806 recalls, newest first
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.
Class II · Moderate risk
6.66 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
5 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
5 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
5 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
5 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
5 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
5 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.