FDA Drug · 2016
FDA Drug recalls in 2016
RecallRadar indexes 1,254 FDA Drug recall notices published in 2016. By classification: 130 Class I, 963 Class II, 161 Class III.
- Ultimate Herbal Slimcap Capsules, 350 mg*, 30-count bottles, labeled Part 1 of 3, fit firm & fabulous, UPC 5 42423 25422 1
FDA Drug · Class I · 2016-02-24 · Fit Firm And Fabulous - Magnesium Sulfate in Water for Injection, (0.325 mEq Mg++/mL) 40 mg/mL, 2 g Total, 50 mL Single-Dose Container bag, Hospira, Inc., Lake For…
FDA Drug · Class I · 2016-02-24 · Hospira - ACETAMINOPHEN REGULAR-STRENGTH PAIN RELIEVER tablets, 325 mg, 100-count bottle, Distributed by Medline Industries, Inc., Mundelein, ILL 600…
FDA Drug · Class I · 2016-02-24 · Medline Industries - Paricalcitol Capsules, 1 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-663-30
FDA Drug · Class III · 2016-02-24 · Dr Reddy S Laboratories - APEXXX tablets, 300 mg, packaged in 1-count blister cards, Distributed Exclusively by: Nuway Distributors, LLC, Orlando, FL USA
FDA Drug · Class I · 2016-02-24 · Nuway Distributors - NATUREAL BURN FAT NATURE, 30-count capsules, packaged in clear plastic bottle, Manufactured for: Inaffit, LLC. P.O. Box 34056, Bethesda, MD…
FDA Drug · Class I · 2016-02-24 · Inaffit - papaverine phentolamine prostaglandin
FDA Drug · Class II · 2016-02-24 · Abbott S Compounding Pharmacy - papaverine prostaglandin 30 mg/30 mcg/mL, 5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 9…
FDA Drug · Class II · 2016-02-24 · Abbott S Compounding Pharmacy - papaverine phentolamine prostaglandin
FDA Drug · Class II · 2016-02-24 · Abbott S Compounding Pharmacy - papaverine phentolamine prostaglandin
FDA Drug · Class II · 2016-02-24 · Abbott S Compounding Pharmacy - Rhino 7 Platinum 3000, Single Blister Packs, distributed By Rhino 7, Made in USA
FDA Drug · Class I · 2016-02-24 · Msnv - papaverine phentolamine prostaglandin
FDA Drug · Class II · 2016-02-24 · Abbott S Compounding Pharmacy - Hydroxycobalamine 30 mg/mL, 90 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
FDA Drug · Class II · 2016-02-24 · Abbott S Compounding Pharmacy - papaverine phentolamine prostaglandin
FDA Drug · Class II · 2016-02-24 · Abbott S Compounding Pharmacy - hydroxyprogesterone w/ pres
FDA Drug · Class II · 2016-02-24 · Abbott S Compounding Pharmacy - Bupivacaine, 0.25%, 450 mL, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
FDA Drug · Class II · 2016-02-24 · Abbott S Compounding Pharmacy - testosterone cypionate, 100 mg/mL, 10 mL unit size, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
FDA Drug · Class II · 2016-02-24 · Abbott S Compounding Pharmacy - papaverine phentolamine prostaglandin
FDA Drug · Class II · 2016-02-24 · Abbott S Compounding Pharmacy - Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) 90 count (NDC 00781-5938-92) bottles, Rx Only, Manufactured by…
FDA Drug · Class III · 2016-02-17 · Sandoz - Morphine Sulfate, 2 mg per mL (60 mg per 30 mL) 30 mL total volume in a 35 mL Monoject Barrel Syringes in Sodium Chloride 0.9%, Rx only, Co…
FDA Drug · Class I · 2016-02-17 · Pharmedium Services - SyrSpend SF, Suspending Base, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneous…
FDA Drug · Class II · 2016-02-17 · Fagron - Candesartan Cilexetil Tablets, 16 mg, 30 Tablets (5 x 6) blister pack, Rx, Distributed by: American Health Packaging Columbus, Ohio 43217,…
FDA Drug · Class III · 2016-02-17 · Amerisource Health Services - SyrSpend SF, Suspending Base, Grape Flavored, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist i…
FDA Drug · Class II · 2016-02-17 · Fagron - Haloperidol Oral Solution, USP (Concentrate) 2 mg/mL 15 mL amber bottle, Rx Only, Manufactured by Silarx Pharmaceuticals Inc
FDA Drug · Class II · 2016-02-17 · Safecor Health - Midazolam HCl Syrup, 10 mg/5 mL, 5 mL unit dose cups, packaged in 2 shelf boxes, one shelf box containing 72 cups and one shelf box contain…
FDA Drug · Class II · 2016-02-17 · Safecor Health - Pramipexole Dihydrochloride Tablets 0.125 mg, 90 Ct Bottles, Rx Only
FDA Drug · Class II · 2016-02-17 · Macleods Pharma Usa - SyrSpend SF, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneous preparation of o…
FDA Drug · Class II · 2016-02-17 · Fagron - Lyrica (pregabalin) capsules, 75 mg, 90-count bottle, Rx only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY, NY 10017, NDC 0071…
FDA Drug · Class II · 2016-02-10 · Pfizer - Clonazepam Tablets, USP, 0.5 mg, 100-count carton, Rx only, Manufactured by Mylan Pharmaceuticals Inc., Morgantown, WV, 26505, NDC:51079-88…
FDA Drug · Class III · 2016-02-10 · Mylan Institutional D B A Udl Laboratories - Lyrica (pregabalin) capsules, 50 mg, 90-count bottle, Rx only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY, NY 10017, NDC 0071…
FDA Drug · Class II · 2016-02-10 · Pfizer - Nystatin, USP Powder for Rx compounding, 50 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0405-05, UPC 305740404058
FDA Drug · Class II · 2016-02-10 · Perrigo - Nystatin, USP Powder for Rx compounding, 150 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0404-15, UPC 305740404157
FDA Drug · Class II · 2016-02-10 · Perrigo - Phenylephrine (PF) 100 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 500 mcg/ 5mL, Rx only, PHARMAKON Pharmac…
FDA Drug · Class II · 2016-02-03 · Pharmakon Pharmaceuticals - GENTAMICIN, Packaged as a) 70MG in 70ML Homepumps, b) 80MG in 80ML Homepumps, and c) 375MG in a 75ML Homepumps, Rx Only
FDA Drug · Class II · 2016-02-03 · Sentara Enterprises - Morphine Sulfate (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.1 mg/ 1mL, Rx only, PHARMAKON Pharma…
FDA Drug · Class II · 2016-02-03 · Pharmakon Pharmaceuticals - CLINDAMYCIN 120MG in NS, Package in 20ML Homepumps, Rx Only
FDA Drug · Class II · 2016-02-03 · Sentara Enterprises - CEFAZOLIN, Packaged as a) 625MG in 6.2ML Syringes, b) 2GM in 20ML Syringes, c) 1GM in 50ML Homepumps, d) 2GM in 100ML Homepumps, and e) 12G…
FDA Drug · Class II · 2016-02-03 · Sentara Enterprises - Invanz (ertapenem) Injection Recon Soln in NS, Packaged as a) 500MG in 50ML Homepumps and b) 1 GM in 100ML Homepumps, Rx Only
FDA Drug · Class II · 2016-02-03 · Sentara Enterprises - Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 1 mg/ 1mL, Rx only, PHARMAKON Pharmaceutical…
FDA Drug · Class II · 2016-02-03 · Pharmakon Pharmaceuticals - POTASSIUM CHLORIDE in D 5 1/2NS, Packaged in a) 40 mEq KCL/LITER 1000ML Homepumps and b) 160 mEq KCL/LITER 500ML Homepumps, Rx Only
FDA Drug · Class II · 2016-02-03 · Sentara Enterprises - PENICILLIN in D5W, Packaged as a)36MU in 360ML Homepumps and b) 51MU in 510ML Homepumps, Rx Only
FDA Drug · Class II · 2016-02-03 · Sentara Enterprises - Glycopyrrolate 0.2 mg/mL, injectable packed in syringes, Total dosage 1 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc
FDA Drug · Class II · 2016-02-03 · Pharmakon Pharmaceuticals - Nafcillin 2GM in NS, Packaged in 50ML Homepumps, Rx Only
FDA Drug · Class II · 2016-02-03 · Sentara Enterprises - Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 1 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharm…
FDA Drug · Class II · 2016-02-03 · Pharmakon Pharmaceuticals - MORPHINE 10MG/ML in NS, Packaged in a) 150ML Homepumps and b) 250ML Homepumps, Rx Only
FDA Drug · Class II · 2016-02-03 · Sentara Enterprises - Tobramycin 120MG, Packaged in 150ML Homepumps, Rx Only
FDA Drug · Class II · 2016-02-03 · Sentara Enterprises - Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-735-01) and b) 15 mL Bottles (NDC: 24208-…
FDA Drug · Class III · 2016-02-03 · Bausch And Lomb - Ketamine 100 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc
FDA Drug · Class II · 2016-02-03 · Pharmakon Pharmaceuticals - AZACTAM (aztreonam) 2GM in NS, Packaged in 100ML Homepumps, Rx Only
FDA Drug · Class II · 2016-02-03 · Sentara Enterprises - Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 4 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharm…
FDA Drug · Class II · 2016-02-03 · Pharmakon Pharmaceuticals - Dextrose-NaCl (D5-1/2NS) in NS, Packaged in a) 1700ML Homepumps, b) 1800ML Homepumps, and c) 1920ML Homepumps, Rx Only
FDA Drug · Class II · 2016-02-03 · Sentara Enterprises - Guaifenesin DM Cherry liquid (guaifenesin 100 mg/5 mL and Dextromethorphan HBr 5 mg/5 mL), packaged in 4oz. bottles, co-packaged with a dos…
FDA Drug · Class II · 2016-02-03 · Perrigo - Ketamine 50 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc
FDA Drug · Class II · 2016-02-03 · Pharmakon Pharmaceuticals - Levofloxacin Tablets USP, 500 mg, packaged in 100-count (10 x 10) blister cards per carton, individual blisters labeled UPC (01) 003 68084…
FDA Drug · Class II · 2016-02-03 · Amerisource Health Services - Lidocaine HCI (PF) Inj, USP 2%, injectable packed in syringes, Total dosage 100 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc
FDA Drug · Class II · 2016-02-03 · Pharmakon Pharmaceuticals - Ampicillin/Sulbactam 12GM in NS, Packaged in 600ML Homepumps, Rx Only
FDA Drug · Class II · 2016-02-03 · Sentara Enterprises - Midazolam 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 2 mg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc
FDA Drug · Class II · 2016-02-03 · Pharmakon Pharmaceuticals - Dextrose-5% Lactated Ringers, Packaged in 3000ML Homepumps, Rx Only
FDA Drug · Class II · 2016-02-03 · Sentara Enterprises - Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 25 mg/ 5mL, Rx only, PHARMAKON Pharmaceutica…
FDA Drug · Class II · 2016-02-03 · Pharmakon Pharmaceuticals - HYDROMORPHONE HCL, Packaged as a) 2.5MG in 1ML Syringes, b) 150MG in 75ML Homepumps, c) 125MG in 125ML Homepumps, d) 250MG in 125ML Homepum…
FDA Drug · Class II · 2016-02-03 · Sentara Enterprises - ASCORBIC ACID 500MG/Syringe, Packaged in 1ML Syringes, Rx Only
FDA Drug · Class II · 2016-02-03 · Sentara Enterprises - Midazolam (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.5 mg/ 1mL, Rx only, PHARMAKON Pharmaceutica…
FDA Drug · Class II · 2016-02-03 · Pharmakon Pharmaceuticals - Lactated Ringers, Packaged in a) 1500ML Homepumps, b) 2800ML Homepumps, and c) 3600ML Homepumps, Rx Only
FDA Drug · Class II · 2016-02-03 · Sentara Enterprises - MYCAMINE (micafungin sodium) 150MG, Packaged in 150ML Homepumps, Rx Only
FDA Drug · Class II · 2016-02-03 · Sentara Enterprises - Guaifenesin Grape liquid 100 mg/5 mL, packaged in 4oz. bottles, co-packaged with a dosing cup in a carton and sold under the following: a)…
FDA Drug · Class II · 2016-02-03 · Perrigo - Fentanyl Citrate (PF) 50 mcg/mL, injectable packed in syringes a) Total dosage 250 mcg/ 5mL, b) Total dosage 100 mcg/ 2mL, Rx only, PHARMAK…
FDA Drug · Class II · 2016-02-03 · Pharmakon Pharmaceuticals - CUBICIN (daptomycin) in NS, Packaged as a) 350MG in 7ML Syringes, b)365MG in 7.3ML Syringes, c) 380MG in 7.6ML Syringes, d) 400MG in 8ML Sy…
FDA Drug · Class II · 2016-02-03 · Sentara Enterprises - MEROPENEM in NS, Packaged as a) 1000MG in 250ML Homepumps, and b) 2GM in 100ML Homepumps, Rx Only
FDA Drug · Class II · 2016-02-03 · Sentara Enterprises - ONDANSETRON HCL 8MG, Packaged in 100ML Homepumps
FDA Drug · Class II · 2016-02-03 · Sentara Enterprises - GANCICLOVIR in NS, Packaged as a) 320MG in 64ML Homepumps and b) 2440MG in 488ML Homepumps, Rx Only
FDA Drug · Class II · 2016-02-03 · Sentara Enterprises - Parenteral Amino Acid Infusion 10%, Packaged in a) 780ML Homepumps, b) 1000ML Homepumps, c) 1140ML Homepumps, d) 1152ML Homepumps, e) 1400M…
FDA Drug · Class II · 2016-02-03 · Sentara Enterprises - Solu-Cortef (hydrocortisone) 1MG in NS, Packaged in 0.1ML Syringe, Rx Only
FDA Drug · Class II · 2016-02-03 · Sentara Enterprises - ZOSYN (pipericillin/tazobactam) in NS, Packaged as a) 3.375GM in 50ML Homepumps, b) 4.5GM in 100ML Homepumps, c) 18GM in 267ML Homepumps, d…
FDA Drug · Class II · 2016-02-03 · Sentara Enterprises - Succinylcholine 20 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc
FDA Drug · Class II · 2016-02-03 · Pharmakon Pharmaceuticals - Rocuronium 10 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc
FDA Drug · Class II · 2016-02-03 · Pharmakon Pharmaceuticals - Milrinone in 0.45% NS, Packaged as a) 52MG in 65ML Homepumps, b) 80MG in 100ML Homepumps, c) 92MG in 115ML Homepumps, d) 104MG in 130ML Hom…
FDA Drug · Class II · 2016-02-03 · Sentara Enterprises - FLUCONAZOLE IN NACL 400MG in NS, Packaged in 200ML Homepumps, Rx Only
FDA Drug · Class II · 2016-02-03 · Sentara Enterprises - CEFEPIME, Packaged a) 1GM in 50ML Homepumps, b) 2GM in 100ML Homepumps, and c) 12GM in 600ML Homepumps, Rx Only
FDA Drug · Class II · 2016-02-03 · Sentara Enterprises - VANCOMYCIN HCL, Packaged as: a) 600MG in 120ML Homepumps, b) 750MG in 150ML Homepumps, c) 850MG in 170ML Homepumps, d) 1GM in 200ML Homepum…
FDA Drug · Class II · 2016-02-03 · Sentara Enterprises - CEFTRIAXONE in NS, Packaged as a) 1GM in 50ML Homepumps, b) 2GM in 100ML Homepumps, and c) 8GM in 200ML Homepumps, Rx Only
FDA Drug · Class II · 2016-02-03 · Sentara Enterprises - Tropicamide Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-585-59) and b) 15 mL Bottles (NDC: 24208-585-64), Rx Only
FDA Drug · Class III · 2016-02-03 · Bausch And Lomb - Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.25 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Ph…
FDA Drug · Class II · 2016-02-03 · Pharmakon Pharmaceuticals - Ondansetron 2 mg/mL, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc
FDA Drug · Class II · 2016-02-03 · Pharmakon Pharmaceuticals - Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 16 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Phar…
FDA Drug · Class II · 2016-02-03 · Pharmakon Pharmaceuticals - Tropicamide Ophthalmic Solution USP, 0.5%, Packaged in 15 mL Bottles, Rx Only
FDA Drug · Class III · 2016-02-03 · Bausch And Lomb - SOLUMEDROL (methylprednisolone succinate) 1GM in NS, Packaged in 100ML Homepumps, Rx Only
FDA Drug · Class II · 2016-02-03 · Sentara Enterprises - Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.0625 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON…
FDA Drug · Class II · 2016-02-03 · Pharmakon Pharmaceuticals - Midazolam (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.2 mg/ 2mL, Rx only, PHARMAKON Pharmaceutica…
FDA Drug · Class II · 2016-02-03 · Pharmakon Pharmaceuticals - Morphine Sulfate (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.5 mg/ 1mL, Rx only, PHARMAKON Pharma…
FDA Drug · Class II · 2016-02-03 · Pharmakon Pharmaceuticals - Epinephrine (PF) 10 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, PHARMAKON Pharmaceutic…
FDA Drug · Class II · 2016-02-03 · Pharmakon Pharmaceuticals - Cancidas (caspofungin acetate) 58.4MG in NS, Packaged in 116.8ML Homepumps, Rx Only
FDA Drug · Class II · 2016-02-03 · Sentara Enterprises - DOBUTAMINE HCL in D5W, Packaged as a) 240MG in 60ML Homepumps and b) 1520MG in 380ML Homepumps, Rx Only
FDA Drug · Class II · 2016-02-03 · Sentara Enterprises - INTRALIPID (fat emulsion), Packaged in a) 27ML Homepumps, b) 125ML Homepumps, c) 1800ML Homepumps, d) 2000ML Homepumps e) 2350ML Homepumps,…
FDA Drug · Class II · 2016-02-03 · Sentara Enterprises - SOD CHLORIDE (Sodium Chloride), Packaged in a) 0.9% in 30ML Homepumps, b) 0.9% 218ML Homepumps, c) 0.45% in 500ML Homepumps, d) 0.9% in 500…
FDA Drug · Class II · 2016-02-03 · Sentara Enterprises - Energique, Homeopathic Remedy, Joint Pain & Stiffness Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0133-1, Dist. by Energique,…
FDA Drug · Class II · 2016-01-27 · Grato Holdings - Bevacizumab 2.5 mg/0.1 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal injection, Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite…
FDA Drug · Class II · 2016-01-27 · Pine Pharmaceuticals - Energique, Homeopathic Remedy, Shingles Pain & Ulceration Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0137-1, Dist. by Energi…
FDA Drug · Class II · 2016-01-27 · Grato Holdings - Energique, Homeopathic Remedy, Skin Irritant & Healing Support, Topical Spray, 1 fl oz bottle, NDC 44911-0136-1, Dist. by Energique, Inc.,…
FDA Drug · Class II · 2016-01-27 · Grato Holdings - IT Custom Compound (BC) Baclofen 2000 mcg/ml, Clonidine 2 mcg/ml 40 ml PF syringe, FOR INTRATHECAL USE ONLY, Rx Only, Compounded by Amerita…
FDA Drug · Class II · 2016-01-27 · Amerita Specialty Infusion Services - Baclofen 1 mg/ml in 40 ml NS syringe, FOR INTRATHECAL USE ONLY, Rx Only, Compounded by Amerita, Inc., Prescott, AZ 86305-1614
FDA Drug · Class II · 2016-01-27 · Amerita Specialty Infusion Services
Other years
2026 (565) · 2025 (765) · 2024 (657) · 2023 (1,252) · 2022 (1,349) · 2021 (1,016) · 2020 (1,035) · 2019 (2,152) · 2018 (1,426) · 2017 (1,073) · 2016 (1,254) · 2015 (2,020) · 2014 (1,562) · 2013 (1,377) · 2012 (434)