Class I · High risk Ongoing
GoHARD 25000, Male Sexual Enhancement, Honey, 100% Natural, UPC: N/A.
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
FDA Drug Recalls
220 recalls · Class I, newest first
Class I · High risk Ongoing
Pink Pussycat Honey, net wt: 20gx12 sachets, UPC 7 918750 046557
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk Ongoing
Samurai-X Honey 6800, UPC 2 56891 27553 3.
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk Ongoing
Flower Power, CBD infused Female Enhancement, 59 ml bottle, UPC 0 678741 351646.
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk Ongoing
Weiner Boner Honey, 12g packet, 100% Organic Formula.
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk Ongoing
Spanish Fly 22K capsules, 2-count box, UPC 0 664979 979455
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk Ongoing
Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous Infusion Only, 20 mL Multiple-Dose Vial, Rx Only…
Reason Presence of Particulate Matter.
Class I · High risk Ongoing
Methocarbamol Injection, USP 1000mg/10mL, (100mg/mL), 10 mL Single-Dose Vial packed 25 vials per carton, Rx Only, Mfd. in India…
Reason Presence of Particulate Matter
Class I · High risk Ongoing
Arize Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Natural Herbal Remedies, LLC, Cheyenne, WY…
Reason Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved…
Class I · High risk Ongoing
SCHWINNNG Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Today the World LLC, Vancouver, WA 98683
Reason Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved…
Class I · High risk Ongoing
Sustain Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by VSD Productions, Inc. Las Vegas, Nevada
Reason Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared tadalafil, an ingredient found in FDA approved…
Class I · High risk Ongoing
To the Moon Capsules, Horny Goat Weed, 1000 mg, packaged in a box containing a 10-count blister card, Distributed By: Integrity…
Reason Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
Class I · High risk Ongoing
RAM IT, Horny Goat Weed, dietary supplement capsules, 1000 mg, packaged in a box containing a 10-count blister card, Distributed…
Reason Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
Class I · High risk Ongoing
Neptune's Fix, Tianeptine Tablets Extended Relief, Twenty Tablets per Box, Wide Awake, 3000 mg (150 mg Per Tablet), Distributed…
Reason Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Class I · High risk Ongoing
Neptune's Fix, Tianeptine Extra Strength Elixir, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N. Gould…
Reason Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Class I · High risk Ongoing
Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N. Gould…
Reason Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Class I · High risk Ongoing
VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, for IV use only; Leiters 13796 Compark Blvd…
Reason Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I · High risk Ongoing
VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only; Leiters 13796 Compark Blvd…
Reason Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I · High risk Ongoing
PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Item F3352, for IV use only; Leiters 13796 Compark Blvd…
Reason Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I · High risk Ongoing
PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for IV use only; Leiters 13796 Compark Blvd…
Reason Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I · High risk Ongoing
FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3342, for IV use only; Leiters 13796 Compark…
Reason Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I · High risk Ongoing
FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355, for IV use only; Leiters 13796 Compark…
Reason Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I · High risk Ongoing
Robitussin Honey CF Max Nighttime Adult (Acetaminophen 650 mg, Diphenhydramine HCl 25mg), 8 FL OZ (237 mL) bottle, Distributed…
Reason Microbial Contamination of Non-Sterile Products
Class I · High risk Ongoing
Robitussin Honey CF Max Non-Drowsy Adult (Acetaminophen 650mg, Dextromethorphan HBr 20 mg), a) 4 FL OZ (118mL) and b) 8 FL OZ…
Reason Microbial Contamination of Non-Sterile Products
Class I · High risk Ongoing
Bleomycin for Injection, USP, 15 units per vial, 1 single dose glass fliptop vial, Rx Only, Distributed by: Hospira, Inc., Lake…
Reason Presence of particulate matter: glass