Class I · High risk Terminated
Magnesium Sulfate 2 grams in Dextrose 5% for Injection, in 50 mL Plastic Infusion Bags, Med Prep Consulting Inc., Tinton Falls…
Reason Non-Sterility; mold contamination
FDA Drug Recalls
1,739 recalls · Class I, newest first
Class I · High risk Terminated
Night Bullet Capsules, supplied in 1 count packets, produced by Green Planet Inc, Riverside, CA
Reason Marketed Without an Approved NDA/ANDA; product contains analogues of sildenafil and tadalafil which are active pharmaceutical ingredients in…
Class I · High risk Terminated
MAXILOSS Weight Advanced, 225 mg proprietary blend of herbs, supplied in 36 count capsules in Green & Blue Boxes, Formulated and…
Reason Marketed Without an Approved NDA/ANDA: product contains sibutramine, a previously approved FDA drug removed from the U.S. marketplace for safety…
Class I · High risk Terminated
Vistide (cidofovir) Injection, 375 mg (75 mg/mL), 5 mL single-use vial, Rx only, Manufactured for: Gilead Sciences, Inc., Foster…
Reason Presence of Particulate Matter: Particulate matter was found in some vials of Vistide (cidofovir injection).
Class I · High risk Terminated
Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA…
Reason Non-Sterility: Confirmed customer complaint of product contaminated with mold.
Class I · High risk Terminated
Reumofan Plus, 30-count tablets per bottle, distriubted by Reumofan Plus USA, LLC and Reumofan USA, LLC, Springfield, PA, and…
Reason Marketed without an approved NDA/ANDA: Product may contain undeclared active pharmaceutical ingredients Diclofenac Sodium, Dexamethasone, and…
Class I · High risk Terminated
Mitosol (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use (NDC 49771-002-01), 3 kits per box (NDC 49771-002-03), Rx…
Reason Non-Sterility: one or more components of the kit have been found to be contaminated with yeast.
Class I · High risk Terminated
Rugby NATURAL IRON SUPPLEMENT Ferrous Sulfate, 5 gr (325 mg), 100 TABLETS, Mfd for: RUGBY LABORATORIES, INC. DULUTH, GEORGIA…
Reason Labeling; Label Mixup; bottles of Ferrous Sulfate actually contains Meclizine HCl (indicated for motion sickness)
Class I · High risk Terminated
Super Power capsules, Proprietary Blend 570 mg, packaged in 2-count capsules per blister pack, Distributed by: Freedom Trading…
Reason Marketed Without An Approved NDA/ANDA: This dietary supplement has been found to contain sildenafil, an FDA approved drug for the treatment of male…
Class I · High risk Terminated
SLIMDIA Revolution capsules, 30-count capsules per bottle, Yerba Naturals, 19685 Varda Ave., Buena Park, CA.
Reason Marketed Without an Approved NDA/ANDA: All lots of the dietary supplement Slimdia Revolution are being recalled because they contain sibutramine, a…
Class I · High risk Terminated
Zicam Extreme Congestion Relief (oxymetazoline HCl) nasal gel, 0.05%, 0.50 fl. oz. (15 mL) spray bottle, Developed and…
Reason Microbial Contamination of Non-Sterile Products: Product may be contaminated with Burkholderia cepacia.
Class I · High risk Terminated
CASANOVA Capsules, 450 mg, MALE SEXUAL ENHANCER, supplied i n1 count blister packs, UPC 736211906892; Distributed by: Casanova…
Reason Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients…
Class I · High risk Terminated
Mojo nights SUPREME Capsules, 1000 mg, Male Sexual Enhancer, supplied in 1 count blister packs, UPC 610585435915; Distributed By…
Reason Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients…
Class I · High risk Terminated
Mojo nights Capsules, Male Sexual Enhancer, supplied in 1 and 5 count blister packs, Distributed By: Mojo Health, Pompano Beach…
Reason Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients…
Class I · High risk Terminated
BLUE Diamond PLATINUM Capsules, 1000 mg, supplied in 1, 5 and 10 count blister packs, Distributed By: DH Distribution Los…
Reason Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients…
Class I · High risk Terminated
BLUE Diamond Pill, supplied in 1, 5 and 10 count blister packs, Male Sexual Enhancement, Distributed By: DH Distribution Los…
Reason Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients…
Class I · High risk Terminated
libigrow XXXTREME Capsules, MAXIMUM STRENGTH FORMULA, 1000 mg, supplied in 1, 5 and 10 count blister packs, Distributed By Kretek…
Reason Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients…
Class I · High risk Terminated
libigrow capsules, PERFORMANCE ENHANCER, supplied in 1, 5 and 10 count blister packs, Distributed By: H & K Nutraceuticals Los…
Reason Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients…
Class I · High risk Terminated
Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg; 100 Tablets (5 x 20), 5 cards each containing 20 blistered…
Reason Superpotent (Multiple Ingredient) Drug: Oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
Class I · High risk Terminated
WOW, Health Enterprises, Dietary Supplement, 30 Caplets, Distributed by: Health Enterprises, 1002 E 5th St., Canton, SD…
Reason Marketed without an Approved NDA/ANDA: Brower Enterprises Inc., is recalling its WOW Health Enterprises Dietary Supplement, because it contains…
Class I · High risk Terminated
Hydrocodone bitartrate and acetaminophen Tablets, USP, 10 mg/500 mg, packaged in a) 30-count bottles, NDC 0603-3888-16; b)…
Reason Superpotent (Multiple Ingredient) Drug: Complaint received of oversized tablets.
Class I · High risk Terminated
Cyanocobalamin 1000 mcg/ml, injection 30 mL, MDV, For Office Use Only, Green Valley Drugs, Manufactured by Green Valley…
Reason Non-Sterility: Green Valley Drugs received positive sterility results from their testing lab on two lots of Methylprednisolone Preservative Free 40…
Class I · High risk Terminated
Methylprednisolone Preservative Free 40 mg/ml Injectible Suspension, 1 mL Vials and 2 mL Vials and 1 mL pre-filled syringes, For…
Reason Non-Sterility: Green Valley Drugs received positive sterility results from their testing lab on two lots of Methylprednisolone Preservative Free 40…
Class I · High risk Terminated
Isovue -300 (Iopamidol) Injection 61% Prefilled, 10 x 100 mL Power Injector Syringe, Rx Only, Manufactured for Bracco Diagnostics…
Reason Presence of Particulate Matter; fibers identified as cellulose and polyvinyl
Class I · High risk Terminated
Isovue -370 (Iopamidol) Injection 76%, Prefilled 10 x 75 mL (NDC 0270-1316-66), 10 x 100 mL (NDC 0270-1316-67), 10 x 125 mL (NDC…
Reason Presence of Particulate Matter; fibers identified as cellulose and polyvinyl