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.

• Baclofen USP powder, packaged in (a) 25gm (4 oz container), (b) 100gm (16 oz container), (c) 500 gm (70 oz container), and (d) 1000 gm (120…
  FDA Drug · Class II · 2016-01-27 · Freedom Pharmaceuticals
• Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg DOUBLE STRENGTH, 100-count bottle, Rx only, Mfg. by: Mutual Pharmaceutical Co…
  FDA Drug · Class II · 2016-01-27 · Mutual Pharmaceutical
• Bromfenac Ophthalmic Solution 0.09%, a) 2.5 mL bottles (NDC 0378-7110-35) and b) 5 mL bottles (NDC 00378-7109-35), Rx only, Mylan Pharmaceu…
  FDA Drug · Class II · 2016-01-27 · Mayne Pharma Usa
• Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 7-count (NDC 55289-791-07), b) 14-count (NDC 55289-791-14), c) 28-count (NDC…
  FDA Drug · Class III · 2016-01-27 · Pd Rx Pharmaceuticals
• Energique, Homeopathic Remedy, Headache Pain & Sinus Pressure Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0134-1, Dist. by En…
  FDA Drug · Class II · 2016-01-27 · Grato Holdings
• Bevacizumab 2 mg/0.08 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal, Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonaw…
  FDA Drug · Class II · 2016-01-27 · Pine Pharmaceuticals
• Bevacizumab 1.25 mg/0.05 mL filled to 0.06 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal, Rx -- Pine Pharmaceuticals, 100 Colvin Woods…
  FDA Drug · Class II · 2016-01-27 · Pine Pharmaceuticals
• Energique, Homeopathic Remedy, Muscle/Tendon Pain & Stress Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0132-1, Dist. by Energ…
  FDA Drug · Class II · 2016-01-27 · Grato Holdings
• Bevacizumab 1.25 mg/0.05 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Ton…
  FDA Drug · Class II · 2016-01-27 · Pine Pharmaceuticals
• Energique, Homeopathic Remedy, First Aid Pain & Trauma Relief, 1 fl oz (30 ml) bottles, NDC 44911-0135-1, Dist. by Energique, Inc., Woodbin…
  FDA Drug · Class II · 2016-01-27 · Grato Holdings
• Lindane Lotion, USP 1%, For External use Only, Rx Only, 2 fl oz (60 mL) bottle, MGP, NDC 60432-833-60
  FDA Drug · Class III · 2016-01-27 · Morton Grove Pharmaceuticals
• HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 10 cap/blister, 100-count carton, Rx only, Packaged and Distributed by American Health Packagin…
  FDA Drug · Class II · 2016-01-20 · Amerisource Health Services
• Domperidone BP, Active Pharmaceutical Ingredient for Prescription Compounding, packaged in a) 5 gm (NDC: 52372-0898-01), b) 25 gm (NDC: 523…
  FDA Drug · Class II · 2016-01-20 · Freedom Pharmaceuticals
• Life-Line DOCUSATE CALCIUM Sodium Free STOOL SOFTENER 240 mg each, 100 softgels per bottle
  FDA Drug · Class III · 2016-01-20 · National Vitamin
• DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets (Mixed Salts of a Single Ent…
  FDA Drug · Class II · 2016-01-20 · Teva Pharmaceuticals Usa
• Azithromycin 500 mg tablets, Rx Only, packaged in a) 1 count, b) 2 count, c) 3 count, and d) 7 count bottles, Packaged by: PD-RX Pharmaceut…
  FDA Drug · Class II · 2016-01-13 · Pd Rx Pharmaceuticals
• 5-methyltetrahydrofolate Calcium (L) (a) 1 gm in 2 oz container NDC: 52372-0855-04
  FDA Drug · Class III · 2016-01-13 · Freedom Pharmaceuticals
• Magnesium Sulfate 7-Hydrate, (For Parenteral Use) USP -GenAR, 100LB, Avantor Performance Materials, Inc., 3472 Corporate Parkway, Suite 200…
  FDA Drug · Class III · 2016-01-13 · Avantor Performance Materials
• EPSOM SALT(Magnesium Sulfate Heptahydrate, USP), 50 lb multi-wall bag, Rx only, Manufactured by PQ Corporation, P.O. Box 840, Valley Forge,…
  FDA Drug · Class III · 2016-01-13 · Pq
• Azithromycin Tablets, USP, 250 mg, Rx Only, packaged in a) 2 count and b) 4 count bottles, Packaged by: PD-RX Pharmaceuticals, Inc., Oklaho…
  FDA Drug · Class II · 2016-01-13 · Pd Rx Pharmaceuticals
• Tobramycin 620 mg/NS 100 mL Accuflo, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
  FDA Drug · Class II · 2016-01-06 · Walgreens Infusion Services
• Nafcillin 12 gm in NS 500 mL bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
  FDA Drug · Class II · 2016-01-06 · Walgreens Infusion Services
• 0.9% Sodium Chloride injection bag, a) 500 mL, b)1000 mL c)2000 mL Bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
  FDA Drug · Class II · 2016-01-06 · Walgreens Infusion Services
• Gentamicin 14.4 mg/sodium chloride 0.9% 30 mL Prefilled syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
  FDA Drug · Class II · 2016-01-06 · Walgreens Infusion Services
• Ceftriaxone 2g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
  FDA Drug · Class II · 2016-01-06 · Walgreens Infusion Services
• Piperacillin/Tazobactam (Zosyn) Accuflo bag, a) 18 g/NS 275 mL b) 4.5 g/NS 100 mL Accuflo, Rx Only, Compounded by Option Care 148, San Anto…
  FDA Drug · Class II · 2016-01-06 · Walgreens Infusion Services
• Primaxin (Imipenem-Cilastatin) 500 mg/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
  FDA Drug · Class II · 2016-01-06 · Walgreens Infusion Services
• 3-in-1 TPN formula daily+overfill Bag, 2000 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
  FDA Drug · Class II · 2016-01-06 · Walgreens Infusion Services
• Vancomycin Injection in NS, Accuflo bag, a) 500 mg/NS 100 mL, b)1G/NS 100 mL, c) Vancomycin 1G/NS 250 mL, d) 1.5G/NS 250 mL e) 750 mg/NS 10…
  FDA Drug · Class II · 2016-01-06 · Walgreens Infusion Services
• Milrinone 0.375 mcg/kg/min D5W bag a) 365 mL, b) 400 mL c) 430 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
  FDA Drug · Class II · 2016-01-06 · Walgreens Infusion Services
• Dextrose 5% and 0.45% Sodium Chloride with KCl 20 mEq 1000 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
  FDA Drug · Class II · 2016-01-06 · Walgreens Infusion Services
• IVIG Gamunex 40 gm (400 mL) Bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
  FDA Drug · Class II · 2016-01-06 · Walgreens Infusion Services
• Sodium Ascorbate (Vitamin C) syringe, a) 500 mg/1 mL syringe, b)1000 mg/2 mL c) 800 mg/1.6 mL, Rx Only, Compounded by Option Care 148, San…
  FDA Drug · Class II · 2016-01-06 · Walgreens Infusion Services
• 0.9% Sodium Chloride/MVI injection 2000 mL Bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
  FDA Drug · Class II · 2016-01-06 · Walgreens Infusion Services
• Cefepime 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
  FDA Drug · Class II · 2016-01-06 · Walgreens Infusion Services
• Dextrose 5% and 0.9% Sodium Chloride injection bag a) 1000 mL, b) 3000 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-50…
  FDA Drug · Class II · 2016-01-06 · Walgreens Infusion Services
• Cefazolin in Accuflo bags, a) 1g/NS 25 mL, b) 2g/NS 25 mL, c) 8g/NS 275 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5…
  FDA Drug · Class II · 2016-01-06 · Walgreens Infusion Services
• Insulin Regular (Human) syringe, a)15 unit/0.15 mL, b) 24 unit/0.24mL syringe, c) 50 unit/0.5 mL, Rx Only, Compounded by Option Care 148, S…
  FDA Drug · Class II · 2016-01-06 · Walgreens Infusion Services
• Famotidine injection syringe a) 10 mg/1 mL b) 80 mg/8 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
  FDA Drug · Class II · 2016-01-06 · Walgreens Infusion Services
• Oxacillin 12 g/NS 270 mL-24 hr Accuflo bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
  FDA Drug · Class II · 2016-01-06 · Walgreens Infusion Services
• Clonidine Hydrochloride Tablets, USP, 0.1 mg, 100-count bottles, Rx only, Packaged by PD-RX Pharmaceuticals, Inc., Oklahoma City, OK 73127,…
  FDA Drug · Class II · 2016-01-06 · Pd Rx Pharmaceuticals
• Heparin injection, Preservative Free, a) 280 units/0.28 mL, b) 350 units/0.35 mL syringe, c) 440 units/0.44 mL, d) 500 units/0.5 mL syringe…
  FDA Drug · Class II · 2016-01-06 · Walgreens Infusion Services
• Meropenem 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
  FDA Drug · Class II · 2016-01-06 · Walgreens Infusion Services
• Phytonadione (Vitamin K) 1 mg/0.1mL Syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
  FDA Drug · Class II · 2016-01-06 · Walgreens Infusion Services
• Remicade (Infliximab) injection, 5 mg/kg bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
  FDA Drug · Class II · 2016-01-06 · Walgreens Infusion Services
• Thiamine 100 mg (1 mL) syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
  FDA Drug · Class II · 2016-01-06 · Walgreens Infusion Services
• Folic Acid 1 mg/0.2 mL syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
  FDA Drug · Class II · 2016-01-06 · Walgreens Infusion Services
• Teflaro 600 mg in 100 mL NS Minibag Plus,Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
  FDA Drug · Class II · 2016-01-06 · Walgreens Infusion Services
• IVIG Gammagard injection bag, a) 13 gm, b) 20 gm, c) 73 gm, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
  FDA Drug · Class II · 2016-01-06 · Walgreens Infusion Services
• Pedi MVI a) 5 mL, b) 10 mL syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
  FDA Drug · Class II · 2016-01-06 · Walgreens Infusion Services
• 0.9% NaCl 1000 mL with Ca 4.65 meq bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
  FDA Drug · Class II · 2016-01-06 · Walgreens Infusion Services
• L-Cysteine 800 mg (16 mL) syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
  FDA Drug · Class II · 2016-01-06 · Walgreens Infusion Services
• Invanz 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
  FDA Drug · Class II · 2016-01-06 · Walgreens Infusion Services
• Clindamycin injection, Accuflo bag, a) 500 mg/NS 50 mL b) 900 mg/NS 100 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5…
  FDA Drug · Class II · 2016-01-06 · Walgreens 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)