FDA Drug · 2013
FDA Drug recalls in 2013
RecallRadar indexes 1,377 FDA Drug recall notices published in 2013. By classification: 71 Class I, 1,147 Class II, 159 Class III.
- buPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carton, 10 blister cards of 10 individually blistered and labeled t…
FDA Drug · Class III · 2013-08-21 · American Health Packaging - Diazepam Injectable, compounded by Pallimed Solutions Pharmacy, Woburn, MA
FDA Drug · Class II · 2013-08-21 · Pallimed Solutions - (No Brand) First Aid Kit, 326 Piece Kit
FDA Drug · Class II · 2013-08-21 · Total Resources Intl - Testosterone Cypionate Injection,compounded by Pallimed Solutions Pharmacy, Woburn, MA
FDA Drug · Class II · 2013-08-21 · Pallimed Solutions - REEVA (triclosan) Antibacterial Hand Soap and Dishwashing Liquid, Green Apple, 0.10%, 24 fl oz. bottle, Distributed by Aldi Inc,. Batavia,…
FDA Drug · Class II · 2013-08-21 · Showline Automotive Products - 3M Tekk Brand Industrial/Construction First Aid Kit, Total Resources Int'l Walnut, CA 91789
FDA Drug · Class II · 2013-08-21 · Total Resources Intl - Alprostadil IN NS Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
FDA Drug · Class II · 2013-08-21 · Pallimed Solutions - Buprenorphine HCl Veterinary Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
FDA Drug · Class II · 2013-08-21 · Pallimed Solutions - DMSO Aqueous Irrigation 50%, compounded by Pallimed Solutions Pharmacy, Woburn, MA
FDA Drug · Class II · 2013-08-21 · Pallimed Solutions - Rifadin (rifampin) capsules, USP, 150 mg, 100-count capsules per bottle, Manufactured by: Fabrique par Sanofi-Aventis Canada Inc., Laval, Q…
FDA Drug · Class II · 2013-08-21 · Sanofi Synthelabo - Acetylcysteine Ophthalmic Solution, compounded by Pallimed Solutions Pharmacy, Woburn, MA
FDA Drug · Class II · 2013-08-21 · Pallimed Solutions - Ranitidine Hydrochloride Tablets, USP, 150 mg, OTC, a) Equate brand Maximum Strength Acid Reducer, 65 count bottle Dist
FDA Drug · Class II · 2013-08-21 · Dr Reddy S Laboratories - Verapamil Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
FDA Drug · Class II · 2013-08-21 · Pallimed Solutions - Belladonna Alkaloids with Phenobarbital Tablets, 1000 count (NDC 0143-1140-10) and 5000 count (NDC 0143-1140-51) PET bottles, Rx Only, Manu…
FDA Drug · Class II · 2013-08-21 · West Ward Pharmaceutical - Testosterone Cypionate/Testosterone Enanthate Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
FDA Drug · Class II · 2013-08-21 · Pallimed Solutions - Tacrolimus Ophthalmic, Pallimed Solutions Pharmacy, Woburn, MA
FDA Drug · Class II · 2013-08-21 · Pallimed Solutions - Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 mL, Single patient infusion vial, RX only, Hospira, Inc., Lake Forest, IL 6004…
FDA Drug · Class II · 2013-08-21 · Hospira - Cidofovir Opthalmic Solution, compounded by Pallimed Solutions Pharmacy, Woburn, MA
FDA Drug · Class II · 2013-08-21 · Pallimed Solutions - Atropine Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
FDA Drug · Class II · 2013-08-21 · Pallimed Solutions - Hydroxyprogesterone CAPR.(G.S.), compounded by Pallimed Solutions Pharmacy, Woburn MA
FDA Drug · Class II · 2013-08-21 · Pallimed Solutions - Clobetasol Propionate Cream, USP, 0.05%, 15 grams, Rx only, Hi-Tech PHARMACAL label, Hi-Tech Pharmacal, Co., Inc., Amityville, NY 11701, ND…
FDA Drug · Class III · 2013-08-21 · Hi Tech Pharmacal - Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution), USP, 37% Organically Bound Iodine, 120 ml bottle, Rx only, Manufactur…
FDA Drug · Class II · 2013-08-21 · Bracco Diagnostics - Prednisone Tablet USP, 20 mg tablets, packaged in blisters of ten (10) tablets per blister card, ten blister cards per carton, Roxanne, Col…
FDA Drug · Class III · 2013-08-21 · Boehringer Ingelheim Roxane - Methylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5348-01
FDA Drug · Class II · 2013-08-14 · Teva Pharmaceuticals Usa - Rifadin, Rifampin capsules, 150 mg, packaged in 30-count bottle, Rx only, Mfd. for Sanofi-Aventis, U.S., LLC, Bridgewater, NJ 08807, NDC 00…
FDA Drug · Class II · 2013-08-14 · Sanofi Us - Methylphenidate Hydrochloride Extended-Release Capsules (LA), 20 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5346-01
FDA Drug · Class II · 2013-08-14 · Teva Pharmaceuticals Usa - Zolpidem Tartrate Tablets 5 mg, 10 tablets per blister, 10 blisters per carton, 100 cartons per box, Rx Only, Manufactured for Wockhardt US…
FDA Drug · Class II · 2013-08-14 · American Health Packaging - Parsel Plus (reference US product: Excedrin Tension Headache) (Acetaminophen 500 mg and Caffeine 65 mg), packaged in 2-count pouches, Distr…
FDA Drug · Class II · 2013-08-14 · Novartis Consumer Health - Reumofan Plus, 30-count tablets per bottle, distriubted by Reumofan Plus USA, LLC and Reumofan USA, LLC, Springfield, PA, and manufactured…
FDA Drug · Class I · 2013-08-14 · Reumofan Plus Usa - 0.9% Sodium Chloride Injection, USP, 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09
FDA Drug · Class I · 2013-08-14 · Hospira - Ondansetron Injection, USP, 4mg/2mL, (2mg/ml), 2mL single-dose Fliptop Vial, Rx only, Sterile, NDC 0409-4755-03, Hospira, Inc, Lake Forest,…
FDA Drug · Class II · 2013-08-14 · Hospira - Lightning ROD capsules, 550 mg/capsule, packaged in 12-count bottles (UPC 6 89076 20297 8)
FDA Drug · Class I · 2013-08-14 · Chang Kwung Products - Terazosin Hydrochloride Capsules,10 mg, 100-count bottle, Rx only, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0…
FDA Drug · Class II · 2013-08-14 · Teva Pharmaceuticals Usa - BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic…
FDA Drug · Class III · 2013-08-14 · Actavis - Methotrexate Injection, USP, Preservative-Free, 1 g/40 mL (25 mg/mL), 40 mL Single Dose Vial, Rx only, Manufactured for: Sandoz Inc., Princ…
FDA Drug · Class I · 2013-08-14 · Sandoz - Excedrin Migraine (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2-count tablets packaged in pouches, Distributed by…
FDA Drug · Class II · 2013-08-14 · Novartis Consumer Health - Introvale (levonorgestrel and ethinyl estradiol) tablets, USP, 0.15 mg/0.03 mg, packaged in 91 day regimen per unit carton, 3 Unit Cartons…
FDA Drug · Class III · 2013-08-14 · Sandoz - Lightning ROD capsules, 500 mg/capsule, packaged in 3-count bottles (UPC 6 89076 20257 2)
FDA Drug · Class I · 2013-08-14 · Chang Kwung Products - Warfarin Sodium Tablets, USP 2 mg, Rx Only, 1000 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distributed b…
FDA Drug · Class I · 2013-08-14 · Zydus Pharmaceuticals Usa - Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx only, Mfg. by: Hospira Healthcare India Pvt
FDA Drug · Class I · 2013-08-14 · Apotex - MERREM I.V. (meropenem for injection), 1 g meropenem equivalent, 30 mL vial, Rx only, Mfd for: AstraZeneca Pharmaceuticals LP, Wilmington,…
FDA Drug · Class II · 2013-08-14 · Astrazeneca Pharmaceuticals - Lisinopril Tablets, USP, 2.5 mg, Rx only, packaged in a) 100-count bottles (NDC 0143-1265-01) and b) 1000-count bottles (NDC 0143-1265-10),…
FDA Drug · Class II · 2013-08-14 · West Ward Pharmaceutical - VersaPharm Incorporated, Ethambutol Hydrochloride Tablets, USP 400 mg 60 tablets, Rx Only, Mfd. for VersaPharm Incorporated Marietta, GA 30…
FDA Drug · Class II · 2013-08-14 · West Ward Pharmaceutical - Latanoprost Ophthalmic Solution, 0.005% (125 mcg/2.5 mL), 2.5 mL bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario Canada M9L…
FDA Drug · Class II · 2013-08-14 · Apotex - Excedrin Extra Strength (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2-ct tablets in pouches b) boxes of 50/2-ct p…
FDA Drug · Class II · 2013-08-14 · Novartis Consumer Health - No Doz, Max Strength (200 mg caffeine) caplets, 2-count caplets per pouch, Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, N…
FDA Drug · Class II · 2013-08-14 · Novartis Consumer Health - Methylphenidate Hydrochloride Extended-Release Capsules (LA), 30 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5347-01
FDA Drug · Class II · 2013-08-14 · Teva Pharmaceuticals Usa - TUMS, Antacid/Calcium Supplement, ULTRA Strength 1000, Assorted Berries, 72 Chewable Tablets, GlaxoSmithKline, Moon Twp, PA 15108, NDC 0135…
FDA Drug · Class III · 2013-08-14 · Glaxosmithkline - Olanzapine Tablets, USP, 10 mg, Rx Only, 30 tablets per bottle, Mfd for: Prasco Laboratories, Mason OH, 45040, USA, Mfd by: Torrent Pharmac…
FDA Drug · Class II · 2013-08-07 · Torrent Pharma - Enablex (darifenacin) Extended Release Tablet, 15 mg per tablet
FDA Drug · Class II · 2013-08-07 · Warner Chilcott Us - Ranitidine Syrup (Ranitidine Oral Solution USP) 15 mg/mL, Rx Only
FDA Drug · Class II · 2013-08-07 · Actavis South Atlantic - DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL container, Rx only, Baxter Healthcare Corporation,…
FDA Drug · Class II · 2013-08-07 · Baxter Healthcare - Belladonna Alkaloids/PB (Belladonna Alkaloids / Phenobarbital) Tablets Phenobarbital USP 16.2 mg, Hyoscyamine Sulfate 0.1037 mg, Atropine S…
FDA Drug · Class II · 2013-08-07 · Physicians Total Care - Night Bullet Capsules, supplied in 1 count packets, produced by Green Planet Inc, Riverside, CA
FDA Drug · Class I · 2013-08-07 · Green Planet - DayQuil Sinex DayTime Sinus Relief (acetaminophen 325 mg and phenylephrine HCl 5 mg) liquicaps and NyQuil Sinex NightTime Sinus Relief (ace…
FDA Drug · Class II · 2013-08-07 · Procter And Gamble - Magnesium Sulfate 2 grams in Dextrose 5% for Injection, in 50 mL Plastic Infusion Bags, Med Prep Consulting Inc., Tinton Falls, NJ 07712
FDA Drug · Class I · 2013-07-31 · Med Prep Consulting - LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, Shade LIGHT 02, UPC 7 47930 00481 3, MAX HUBER RESEARCH LABS I…
FDA Drug · Class III · 2013-07-31 · Max Huber Research Labs - ALCOHOL FREE ANTISEPTIC (cetylpyridinium chloride) Mouth Rinse, 0.07%, mint, 33.8 FL OZ (1 L) bottle, Distributed By The Kroger Co., Cincin…
FDA Drug · Class III · 2013-07-31 · Vi Jon - Sodium Chloride Injection, USP, 0.9%, 20 mL Single-dose Fliptop Plastic Vial, packaged in 25 vial Units per carton, Rx only, Hospira, Inc.,…
FDA Drug · Class II · 2013-07-31 · Hospira - 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 only, Manuf…
FDA Drug · Class I · 2013-07-31 · Mobius Therapeutics - West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10),Rx only, Manufactured by West-ward Pharm…
FDA Drug · Class II · 2013-07-31 · West Ward Pharmaceutical - AmBisome (amphotericin B) liposome for Injection, 50 mg, For Intravenous Infusion Only, Single-Use Vial, Rx Only, Marketed by: Astellas Pha…
FDA Drug · Class II · 2013-07-31 · Gilead Sciences - VIVITROL (naltrexone for extended-release injectable suspension) a) 380 mg vial NDC 65757-303-02, b) 380 mg vial in kit NDC 65757-300-01, R…
FDA Drug · Class II · 2013-07-31 · Alkermes - All Compounded Products, packaged in plastic infusion bags, devices, syringes and glass vials, Med Prep Consulting Inc., Tinton Falls, NJ 0…
FDA Drug · Class II · 2013-07-31 · Med Prep Consulting - AmBisome (amphotericin B) liposome for injection, 50mg vial, single use vial, For Intravenous Infusion Only, Rx Only, Marketed by: Astellas…
FDA Drug · Class II · 2013-07-31 · Astellas Pharma Us - LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, Shade DARK 04, UPC 7 47930 00483 7 --- MAX HUBER RESEARCH LABS…
FDA Drug · Class III · 2013-07-31 · Max Huber Research Labs - West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10), b) 5000-count bottle (NDC 0143-1140-51)…
FDA Drug · Class II · 2013-07-31 · West Ward Pharmaceutical - Pharmalucence Kit for the Preparation of Technetium Tc 99m Sestamibi Injection for Mycardial and Breast Imaging
FDA Drug · Class III · 2013-07-31 · Pharmalucence - LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, Shade MEDIUM 03, UPC 7 47930 00482 0 --- MAX HUBER RESEARCH LA…
FDA Drug · Class III · 2013-07-31 · Max Huber Research Labs - Oxygen, Compressed USP UN1072 Medical Gas supplied in a) 682 litres and b)165 litres cylinders, Rx only, Oklahoma Respiratory Care 800.262.…
FDA Drug · Class II · 2013-07-31 · Oklahoma Respiratory Care - Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, 60-count bottle, Rx only, Manufactured by Watson Laboratories, Inc.,…
FDA Drug · Class II · 2013-07-31 · Watson Laboratories Actavis Florida - Oxycodone and Acetaminophen Capsules, USP 5mg/500 mg, packaged in a)100-count bottle (NDC 0591-0737-01), b) 500-count bottle (NDC 0591-0737…
FDA Drug · Class III · 2013-07-31 · Watson Laboratories - QUETIAPINE Fumarate Tablets 25mg 100 Tablets (10x10) Blister card, Rx, Packaged and Distributed by: American Health Packaging, Columbus, Oh…
FDA Drug · Class II · 2013-07-24 · American Health Packaging - Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx only, Mfg. by: Hospira Healthcare India Pvt
FDA Drug · Class I · 2013-07-24 · Apotex - Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP3 Grade, packaged in bags of various quantities, Church & Dwight Co…
FDA Drug · Class II · 2013-07-24 · Church And Dwight - Estarylla (Norgestimate and Ethinyl Estradiol) Tablets
FDA Drug · Class II · 2013-07-24 · Sandoz - Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM Use, Rx Only, 1 mL vial, APP ) 10 USP Units/mL, 1 mL, APP Phar…
FDA Drug · Class II · 2013-07-24 · Fresenius Kabi Usa - Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP2 Grade, packaged in bags of various quantities, Church & Dwight Co…
FDA Drug · Class II · 2013-07-24 · Church And Dwight - Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, Sodium Bicarbonate U.S.P. No. 4 Granular, Net Wt. 50 lbs. (22.68 kg.) per bag, Manuf…
FDA Drug · Class II · 2013-07-24 · Church And Dwight - Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP5 Grade, packaged in bags of various quantities, Church & Dwight Co…
FDA Drug · Class II · 2013-07-24 · Church And Dwight - Amoxicillin for Oral Suspension, USP 200 mg/5 mL, a) 75 mL bottle NDC 0093-4160-78 and b) 100 mL bottle NDC 0093-4160-73, Rx Only, Manufact…
FDA Drug · Class III · 2013-07-24 · Teva Pharmaceuticals Usa - Medroxyprogesterone acetate, micronized (EP, USP) active pharmaceutical ingredient, Rx only, packaged in 6.0 kg drums (labeled as 6,000 kg)…
FDA Drug · Class III · 2013-07-24 · Bayer Healthcare Pharmaceuticals - Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP1 Grade, packaged in bags of various quantities, Church & Dwight Co…
FDA Drug · Class II · 2013-07-24 · Church And Dwight - Quadmix, compounded by Olympia Pharmacy, Orlando, FL
FDA Drug · Class II · 2013-07-17 · Lowlite Investments - Nicardipine Hydrochloride Injection 25 mg/10 mL (2.5 mg/mL), 10 mL single-use vials, Rx Only, Mfd. by Exela Pharma Sciences, LLC, Lenoir, N…
FDA Drug · Class III · 2013-07-17 · West Ward Pharmaceutical - Vitamin B12 Cyanocobalamin 5000 mcg Injection, compounded by Olympia Pharmacy, Orlando, FL
FDA Drug · Class II · 2013-07-17 · Lowlite Investments - Aminocaproic Acid 0.5mg/ml Injection,compounded by Olympia Pharmacy, Orlando, FL
FDA Drug · Class II · 2013-07-17 · Lowlite Investments - Altrenogest 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
FDA Drug · Class II · 2013-07-17 · Lowlite Investments - Phenylephrine 1 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
FDA Drug · Class II · 2013-07-17 · Lowlite Investments - Stanozolol (50 mg/ml and 100 mg/ml) Injection, compounded by Olympia Pharmacy, Orlando, FL
FDA Drug · Class II · 2013-07-17 · Lowlite Investments - Phentolamine 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
FDA Drug · Class II · 2013-07-17 · Lowlite Investments - Atipamezole 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
FDA Drug · Class II · 2013-07-17 · Lowlite Investments - Pento-Gluc 200 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
FDA Drug · Class II · 2013-07-17 · Lowlite Investments - Progesterone 100 mg/ml in Olive Oil Injection, compounded by Olympia Pharmacy, Orlando, FL
FDA Drug · Class II · 2013-07-17 · Lowlite Investments - Calcium Gluconate 23%, compounded by Olympia Pharmacy, Orlando, FL
FDA Drug · Class II · 2013-07-17 · Lowlite Investments - Gentamicin 0.3% Injection, compounded by Olympia Pharmacy, Orlando, FL
FDA Drug · Class II · 2013-07-17 · Lowlite Investments - Betamethasone Phosphate/Acetate 6 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
FDA Drug · Class II · 2013-07-17 · Lowlite Investments - Meloxicam 5 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
FDA Drug · Class II · 2013-07-17 · Lowlite Investments - Medroxyprogesterone 150 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
FDA Drug · Class II · 2013-07-17 · Lowlite Investments - HCG 125iu/0.25ml (550iu/ml), 3500iu and 10,000iu, compounded by Olympia Pharmacy, Orlando, FL
FDA Drug · Class II · 2013-07-17 · Lowlite Investments
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)