Class II · Moderate risk
Dermamedics Calm and Correct Serum
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
FDA Drug Recalls
14,806 recalls, newest first
Class II · Moderate risk
Dermamedics Complexion Repair Topical Rehydrating Emulsion which…
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Class II · Moderate risk
Dermamedics Baby's Relief Calm and Repair Cream in 2 oz…
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Class II · Moderate risk
Dermamedics Calm & Correct Cream in 2 oz. containers with SKU…
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Class II · Moderate risk
Dermamedics Post Procedure Cream
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Class I · High risk
Xzen Platinum
Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Class I · High risk
ExtenZe 600 mg
Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Class I · High risk
Magic For Men
Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Class I · High risk
MiracleZEN Platinum
Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Class I · High risk
Sexy Monkey
Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Class I · High risk
Boost Ultra
Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Class I · High risk
Xzone Gold
Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Class II · Moderate risk
Heparin Sodium 2000 USP Heparin Units per 1000 mL
Lack of Assurance of Sterility; potential leakage from administrative port.
Class II · Moderate risk
Aminosyn 3.5% M Sulfite-Free
Lack of Assurance of Sterility; potential leakage from administrative port.
Class II · Moderate risk
a) Walgreens Lansoprazole Delayed Release Capsules
Microbial Contamination of Non-Sterile Products: Out-of-specification results for microbial count were observed at the initial stability interval for Lansoprazole Delayed Release Capsules.
Class III · Low risk
Zithromax (azithromycin for injection)
Failed Impurities/Degradation Specifications: Pfizer is recalling certain lots due to out of specification results for azithromycin N-oxide degradant.
Class II · Moderate risk
Mangiacotti - Ginger Lime Hand Sanitizer Spray
Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
Class II · Moderate risk
Mangiacotti - Pomegranate Hand Sanitizer Spray
Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
Class II · Moderate risk
Mangiacotti - Clementine Hand Sanitizer Spray
Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
Class II · Moderate risk
Mangiacotti - Ocean Hand Sanitizer Spray
Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
Class II · Moderate risk
Mangiacotti - Lavender Hand Sanitizer Spray
Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
Class II · Moderate risk
Mangiacotti - Lemon Verbena Hand Sanitizer Spray
Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
Class II · Moderate risk
Carisoprodol Tablets
Presence of Foreign Substance; metal particulates were visually observed in the tablets.
Class I · High risk
Burn 7 Capsules
Marketed Without an Approved NDA/ANDA: Undeclared sibutramine and phenolphthalein in Burn 7 dietary supplement
Class I · High risk
Lidocaine HCl Injection
Presence of Particulate Matter- Confimed customer complaint of particulates embedded in glass container and in contact with product solution.