FDA Drug · 2014
FDA Drug recalls in 2014
RecallRadar indexes 1,562 FDA Drug recall notices published in 2014. By classification: 152 Class I, 1,258 Class II, 152 Class III.
- Propranolol HCl, NET WT 1 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0004
FDA Drug · Class II · 2014-10-22 · Gyma Laboratories - Atorvastatin Calcium 40 MG Tablet, MFG: Apotex NDC# 6050525808
FDA Drug · Class II · 2014-10-22 · Unit Dose Solutions - HYDROXYPROGESTERONE CAPROATE 250 MG/ML (IN SESAME OIL), Rx Only 4 mL INJECTABLE IM USE. Manufactured by Avella Specialty Pharmacy, Phoenix,…
FDA Drug · Class II · 2014-10-22 · Avella - Ketorolac Tromethamine INJECTION, USP, 30 mg per mL, a) 1 mL vial (NDC 25021-701-01) b) 2 mL vial (NDC 25021-701-02), Rx only, Mfd. for SAG…
FDA Drug · Class II · 2014-10-22 · Sagent Pharmaceuticals - Lidocaine HCl Injection, USP, 2%, 20 mg per mL, Preservative-Free, 5 mL Single-Dose Vial, Rx only, For Infiltration and Nerve Block includi…
FDA Drug · Class I · 2014-10-22 · Hospira - TOPIRAMATE Tablets 200 mg, 60 Tablet Bottles, Rx Only
FDA Drug · Class II · 2014-10-22 · Zydus Pharmaceuticals Usa - Clonidine Base Micronized, 55.8 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 12660-0503-01
FDA Drug · Class II · 2014-10-22 · Gyma Laboratories - Vaseretic (enalapril maleate/hydrochlorothiazide) 10/25 mg Tablets, NDC 0187-0146-01, 100 ct. bottles manufactured at Valeant Pharmaceutica…
FDA Drug · Class III · 2014-10-22 · Valeant Pharmaceuticals North America - Clonidine HCL, 97 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0002
FDA Drug · Class II · 2014-10-22 · Gyma Laboratories - Locoid (hydrocortisone butyrate 0.1%), Cream, Net Wt. 15 gm tubes, Rx only, Manufactured for: Onset Dermatologics, LLC, Cumberland, RI 0286…
FDA Drug · Class III · 2014-10-22 · Valeant Pharmaceuticals International - Vasotec (enalapril maleate) tablets, RX only, Manufactured by Valeant Pharmaceuticals International, Inc., Steinbach, MD R5G 1Z7 Canada 2.5…
FDA Drug · Class III · 2014-10-22 · Valeant Pharmaceuticals North America - Hydrocortisone Butyrate Cream 0.1%, Net Wt. 15 gm tubes, Rx only, Manufactured for: Rouses Point Pharmaceuticals, LLC Cranford, NJ 07016 By…
FDA Drug · Class III · 2014-10-22 · Valeant Pharmaceuticals International - Amiodarone HCl Injection, 450 mg/9 mL (50 mg per mL), 9 mL Single-Use Vial, Rx only, Manufactured for Mylan Institutional, LLC, Rockford, I…
FDA Drug · Class II · 2014-10-15 · Mckesson - METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, (present as the hydrochloride), 10 mL cups, Rx only
FDA Drug · Class II · 2014-10-15 · Vistapharm - N-Acetyl Cysteine 20% 4 mL Vial Stock Code: 4133
FDA Drug · Class I · 2014-10-15 · Unique Pharmaceutical - Truvada (200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) tablets, 30 count bottles, Rx only, Manufactured for Gilead Science…
FDA Drug · Class III · 2014-10-15 · Gilead Sciences - Xarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only, Manufactured by: JOLLC, Gurabo, PR 00778 NDC 50458-578-99
FDA Drug · Class II · 2014-10-15 · Janssen Ortho - E-Z- GAS II EFFERVESCENT GRANULES Antacid/Antiflatulent ,4 g (0.14 oz), 50 -count box, Rx Only, Manufactured in USA for E-Z EM, Inc
FDA Drug · Class III · 2014-10-15 · Bracco Diagnostic - All sterile products within expiry
FDA Drug · Class II · 2014-10-15 · Unique Pharmaceutical - Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc
FDA Drug · Class II · 2014-10-15 · Astellas Pharma Us - Metoprolol Succinate Extended-release Tablets, USP 50mg, 90-count Bottles, Rx only, Mfg by Mylan Pharmaceuticals, Inc
FDA Drug · Class II · 2014-10-15 · Mylan Pharmaceuticals - ZyGenerics ATENOLOL Tablets, USP 25 mg 1000 count bottle, Rx Only Manufactured by: Cadila Healthcare Ltd
FDA Drug · Class II · 2014-10-15 · Zydus Pharmaceuticals Usa - Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 50 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, In…
FDA Drug · Class II · 2014-10-08 · Actavis Laboratories Fl - CUBICIN (daptomycin for injection), 500 mg single-use vial, Rx only, Manufactured for: Cubist Pharmaceuticals, Inc., Lexington, MA 02421, N…
FDA Drug · Class I · 2014-10-08 · Cubist Pharmaceuticals - MOJO RISEN, 650 mg, 2 capsule per pouch, Distributed by: Mojo Risen, LLC, Springville, UT 84663
FDA Drug · Class I · 2014-10-08 · Eugene Oregon - DOPamine Hydrochloride and 5% Dextrose INJ, USP, 200 mg per 250 mL, Rx Only, Baxter USA, NDC 0338-1005-02
FDA Drug · Class II · 2014-10-08 · Baxter Healthcare - Black Ant, 2800 mg, four capsules per box, Manufacturer Qinghai Baojiantang Pharmaceutical Co., Ltd
FDA Drug · Class I · 2014-10-08 · Eugene Oregon - Marcaine (bupivacaine HCl) injection, USP, 0.5%, Preservative-Free, 30 mL (150 mg) Single-dose Vial, Rx only, Hospira, Inc., Lake Forest, I…
FDA Drug · Class I · 2014-10-08 · Hospira - AFRICAN BLACK ANT, 2800 mg, 6 capsules per box, produced by: Qinghan Hongwei Bioengineering Company, No. 158, Renmin Road, Xining City
FDA Drug · Class I · 2014-10-08 · Eugene Oregon - Zoledronic Acid Injection 5 mg per 100 mL (0.05 mg/mL), 100 mL single-use bag packaged in a foil overwrap, Rx only, Sterile, For Intravenou…
FDA Drug · Class II · 2014-10-08 · Sagent Pharmaceuticals - CREON (pancrelipase) Delayed-Release Capsules, Lipase 24,000 USP Units, 250 Capsule Bottles, Rx Only
FDA Drug · Class II · 2014-10-08 · Abbvie - All sterile drugs compounded between 2/21/14 and 2/24/14
FDA Drug · Class II · 2014-10-08 · New England Home Therapies - Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, In…
FDA Drug · Class II · 2014-10-08 · Actavis Laboratories Fl - Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, 5000 mL Ambu-Flex II container bags, Rx only, Baxter Healt…
FDA Drug · Class I · 2014-10-08 · Baxter Healthcare - Oxycodone and Acetaminophen Tablets USP 10 mg/325 mg 100 count bottles Rx Only
FDA Drug · Class II · 2014-10-01 · Alvogen - MethylPREDNISolone TABLETS, USP 4 mg, a) 100 count bottles (NDC 0603-4593-21) and b) 21 count blister pack (NDC 0603-4593-15), Rx only, Mfg…
FDA Drug · Class III · 2014-10-01 · Qualitest Pharmaceuticals - Daytrana (methylphenidate transdermal system) patch, Delivers 20 mg over 9 hours (2.2mg/hr), 1 patch per pouch , packaged in 30-count patch…
FDA Drug · Class II · 2014-10-01 · Noven Pharmaceuticals - Rifampin for Injection USP, 600 mg*/vial (Sterile), supplied in sterile glass vials, Rx only For IV Infusion only, individually boxed, Mfd.…
FDA Drug · Class III · 2014-10-01 · Akorn - Potassium Chloride Injection, 10 mEq per 100 mL, Highly Concentrated (100 mEq/L), 100 mL Sterile single dose container bags, Rx only, Baxte…
FDA Drug · Class II · 2014-10-01 · Baxter Healthcare - Buprenorphine Hydrochloride Injection, CIII, 0.3 mg base/mL ,1 mL, 10 Carpuject Sterile Cartridge Units with Luer Lock, Slim-Paks, F Intram…
FDA Drug · Class II · 2014-10-01 · Hospira - Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manufactured by Apotex Inc
FDA Drug · Class III · 2014-10-01 · Apotex - Warfarin Sodium Tablets, USP Crystalline, 2 mg, 100 and 1000 Tablet Bottles, Rx Only
FDA Drug · Class III · 2014-09-24 · Taro Pharmaceuticals U - Dermatend Ultra, mole, wart and skin tag remover, For external use only, Ingredient: Distilled Water, Sanguinaria Canadensis, Vegetable Gly…
FDA Drug · Class II · 2014-09-24 · Solace International - Xzone 1200, 750 mg, one capsule per blister pack, Distributed by: Xzone, Orlando, FL 32789
FDA Drug · Class I · 2014-09-24 · Nova Products - Potassium Chloride Injection, 20 mEq per 50 mL, 50 mL Sterile Single Dose Container bag, Rx only, Baxter Healthcare Corporation, Deerfield,…
FDA Drug · Class I · 2014-09-24 · Baxter Healthcare - 0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporati…
FDA Drug · Class I · 2014-09-24 · Baxter Healthcare - XZONE GOLD, 750 mg, one capsule blister pack, Distributed by: XZONE, Orlando, FL 32789
FDA Drug · Class I · 2014-09-24 · Nova Products - XZEN PLATINUM, 750 mg, 1 capsule per blister pack, Distributed by: XZEN, City of Los Angeles, CA 90012
FDA Drug · Class I · 2014-09-24 · Nova Products - Bupivacaine HCl Inj., USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative-Free, For Nerve Block, Caudal, and Epidural Anesthesia, Not for S…
FDA Drug · Class II · 2014-09-24 · Hospira - 0.9% Sodium Chloride Injection USP, packaged in a) 50 mL VIAFLEX Container bags, NDC 0338-0049-41, Product Code 2B1306
FDA Drug · Class I · 2014-09-24 · Baxter Healthcare - Dermatend Original, mole, wart and skin tag remover, For external use only, Ingredient: Distilled Water, Sanguinaria Canadensis, Vegetable…
FDA Drug · Class II · 2014-09-24 · Solace International - Oxcarbazepine Tablets, 300 mg, 100 tablets per carton (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus,…
FDA Drug · Class I · 2014-09-24 · American Health Packaging - Candesartan Cilexetil and Hydrochlorothiazide Tablets 32 mg/12.5 mg, 90 count bottles, Rx only, Manufactured by: Apotex Research Pvt
FDA Drug · Class III · 2014-09-24 · Apotex - THINOGENICS, WEIGHT LOSS MADE EASY! DIETARY SUPPLEMENT, 30 CAPSULES, 30 Count Bottles, THINOGENICS LLC, Nashville, TN 37203 USA
FDA Drug · Class I · 2014-09-24 · Nature S Universe - COUMADIN FOR INJECTION (Warfarin Sodium for Injection, USP 5 mg Single-Use Vial Rx Only Distributed by Bristol Meyers Squibb Company, Princ…
FDA Drug · Class I · 2014-09-24 · Bristol Meyers Squibb - MOJO RISEN ,670 mg, 2 capsule per pouch, Distributed by: Mojo Risen, LLC, Springville, UT 84663
FDA Drug · Class I · 2014-09-24 · Nova Products - AFRICAN BLACK ANT, 2800 mg, 6 capsules per box, produced by: Qinghan Hongwei Bioengineering Company, No. 158, Renmin Road, Xining City
FDA Drug · Class I · 2014-09-24 · Nova Products - NORepinephrine 4 mg in 250 mL Sodium Chloride0.9%, For IV Use Only, Flexible Bag, Rx only, UNIQUE PHARMACEUTICALS, Inc.Temple, TX USA 76502
FDA Drug · Class II · 2014-09-24 · Unique Pharmaceutical - Black Ant, 4600 mg, four capsules per box, , Manufacturer Timpo Bioengineering Co., Ltd, USA
FDA Drug · Class I · 2014-09-24 · Nova Products - Xzen 1200, 750 mg, six capsules per bottle, Distributed by: xzen, City of Los Angeles, CA 90012
FDA Drug · Class I · 2014-09-24 · Nova Products - XZEN GOLD,750 mg, six capsules per bottle, Distributed by: XZEN, City of Los Angeles, CA 90012
FDA Drug · Class I · 2014-09-24 · Nova Products - Ibuprofen Tablets, USP, 600 mg, 100 tablets per carton (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus…
FDA Drug · Class I · 2014-09-24 · American Health Packaging - 0.9% Sodium Chloride Injection, USP, 500 mL, VIAFLEX Plastic Container, Baxter Healthcare Corporation, Deerfield, IL NDC 0338-0049-03
FDA Drug · Class II · 2014-09-17 · Baxter Healthcare - CHIROTHIN Dietary Supplement, 2 Fl Oz (60 ml), OTC. Manufactured for ChiroNeutraceutical, 877-377-7636, Chesterfield, MO 63005
FDA Drug · Class III · 2014-09-17 · Chironutraceutical - Paroxetine HCL Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for…
FDA Drug · Class II · 2014-09-10 · Apotex - PAXIL CR (Paroxetine HCL) Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manuf…
FDA Drug · Class II · 2014-09-10 · Apotex - PAXIL (Paroxetine HCL) Tablets 40 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Cor…
FDA Drug · Class II · 2014-09-10 · Apotex - Comfort Shield Barrier Cream Cloths with dimethicone a) 8 count NDC 53462-915-80, b) 24 count NDC 53462-915-60, OTC, SAGE PRODUCTS INC., 39…
FDA Drug · Class II · 2014-09-10 · Sage Products - Paroxetine HCL Controlled-Release Tablets 37.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured f…
FDA Drug · Class II · 2014-09-10 · Apotex - Paroxetine HCL Controlled-Release Tablets 12.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured f…
FDA Drug · Class II · 2014-09-10 · Apotex - PAXIL (Paroxetine HCL) Oral Suspension 10 mg/5 mL - 250 mL bottle, Rx Only, Manufactured by GlaxoSmithKline, RTP, NC 27709
FDA Drug · Class II · 2014-09-10 · Apotex - OXYCODONE and ACETAMINOPHEN, USP 10 mg/325 mg, CII, 100 TABLETS, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811…
FDA Drug · Class II · 2014-09-10 · Qualitest Pharmaceuticals - PAXIL (Paroxetine HCL) Tablets 10 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Cor…
FDA Drug · Class II · 2014-09-10 · Apotex - PAXIL CR (Paroxetine HCL) Controlled-Release Tablets 37.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Man…
FDA Drug · Class II · 2014-09-10 · Apotex - PAXIL (Paroxetine HCL) Tablets 20 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Cor…
FDA Drug · Class II · 2014-09-10 · Apotex - MINERAL IV Injection, compounded by Abrams Royal Pharmacy, Inc., Dallas, TX
FDA Drug · Class I · 2014-09-03 · Abrams Royal Pharamacy - VIVITROL (naltrexone for extended-release injectable suspension)
FDA Drug · Class II · 2014-09-03 · Alkermes - LOW Potassium Cardioplegia 792 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150
FDA Drug · Class I · 2014-09-03 · Central Admixture Pharmacy Services - Nicotine Polacrilex Lozenge, 2 mg Mint Mini. 27 Ct Tubes, Over the Counter
FDA Drug · Class III · 2014-09-03 · Perrigo Holland - adenosine 90 mg in 0.9% sodium chloride/90 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150
FDA Drug · Class I · 2014-09-03 · Central Admixture Pharmacy Services - del Nido Cardioplegia with Lidocaine 1052.8 ml, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150
FDA Drug · Class I · 2014-09-03 · Central Admixture Pharmacy Services - Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in 50 mL and 100 mL IV bag, Rx Only
FDA Drug · Class I · 2014-09-03 · Pharmakon Pharmaceuticals - All Unexpired Sterile Drug Products, compounded by Abrams Royal Pharmacy Inc., Dallas, TX
FDA Drug · Class II · 2014-09-03 · Abrams Royal Pharamacy - Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505
FDA Drug · Class III · 2014-09-03 · Mylan Pharmaceuticals - Midazolam HCl 2 mg/ml in 0.9% Sodium Chloride in 30 mL PVC Vial, Rx Only
FDA Drug · Class I · 2014-09-03 · Pharmakon Pharmaceuticals - Glycopyrrolate 0.2 mg/ml, 5 mL pre-filled syringe, Rx Only
FDA Drug · Class II · 2014-09-03 · Pharmakon Pharmaceuticals - PEDIATRIC CARDIOPLEGIA, 255 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150
FDA Drug · Class I · 2014-09-03 · Central Admixture Pharmacy Services - Atropine Sulfate 0.4 mg/ml Injection, USP, Total Dosage 0.8 mg per 2 mL, 3 mL pre-filled syringe, Rx Only
FDA Drug · Class I · 2014-09-03 · Pharmakon Pharmaceuticals - Famotidine for Oral Suspension, USP 40 mg/5 mL, Rx Only, Cherry-Banana-Mint Flavored, Not for Injection, Manufactured by: Novel Laboratorie…
FDA Drug · Class III · 2014-09-03 · Novel Laboratories - Triveen - PRx RNF Capsules, 30-count bottles, Rx only
FDA Drug · Class III · 2014-08-27 · Trigen Laboratories - fentaNYL 5000 mcg/250 mL (20 mcg/mL) in 0.9% Sodium Chloride in a flexable bag, COMPOUNDED DRUG For Institutional or Office Use Only--Not f…
FDA Drug · Class II · 2014-08-27 · Healix Infusion Therapy - fentaNYL 200 mcg/100 mL (2 mcg/mL) and Ropivacaine 0.2% in 0.9% Sodium Chloride 100mL, in flexable bag, COMPOUNDED DRUG For Institutional o…
FDA Drug · Class II · 2014-08-27 · Healix Infusion Therapy - ProSol - sulfite-free (Amino Acid) Injection, 20%, 2000 mL VIAFLEX container bag, Rx only, Baxter Healthcare Corporation, Clinitec Nutritio…
FDA Drug · Class II · 2014-08-27 · Baxter Healthcare - Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx only
FDA Drug · Class III · 2014-08-27 · Mylan Pharmaceuticals - 0.9 % Sodium Chloride Injection, USP, 1000 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation, Deerfield, IL 60015
FDA Drug · Class I · 2014-08-27 · Baxter Healthcare - ePHEDrine Sulfate Injection, USP 25 mg/5 mL (5 mg/mL) Single Use 5 mL Syringe, For IV, IM, or SC injection, Preservative Free, For Office/H…
FDA Drug · Class II · 2014-08-27 · Us Compounding - Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), For I.V. Administration, Rx Only, 20 mL vial, Contains Benzyl Alcohol, Hospira,…
FDA Drug · Class I · 2014-08-27 · Hospira - CYTARAbine for Injection USP, lyophiled in glass vials, 1 gram per vial, Rx only, Distributed by Bedford Laboratories, Bedford, OH 44146, M…
FDA Drug · Class II · 2014-08-27 · Ben Venue Laboratories - fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride in flexable bag, COMPOUNDED DRUG For Institutional or Office Use Only--Not for…
FDA Drug · Class II · 2014-08-27 · Healix Infusion Therapy - fentaNYL 1500 mcg/30 mL (50 mcg/mL) in prefilled syringe, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale Federal Law…
FDA Drug · Class II · 2014-08-27 · Healix Infusion Therapy
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)