Product Recalls in 2019

4,851 recalls issued this year

241

CPSC

1,807

FDA Food

1,788

FDA Drug

1,015

NHTSA

FDA Drug Class II Terminated

Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, Rx Only, 16 FL. oz. (473 mL) bottle, NDC: 59741-262-16 Manufactured by Bio-Pharm Inc., Levittown, PA 19057 US

May 21, 2019 Torrent Pharma Inc 11,112 bottles units
FDA Drug Class II Terminated

Hyoscyamine Oral Drops 0.125 mg/mL, Rx Only, 15 mL bottle (0.5 FL. oz.), NDC: 39328-047-15, Manuf. for Patrin Pharma, Skokie IL 60076.

May 21, 2019 Torrent Pharma Inc 53,520 bottles units
FDA Drug Class II Terminated

Robafen Cough Formula Expectorant (guaifenesin USP 200 mg in each 10 mL), a) 4 Fl. oz. (118 mL) bottle, NDC: 0904-0061-00, b) One Pint ( 473 mL) bottle, NDC: 0904-0061-16, Distributed by Major Pharmac

May 21, 2019 Torrent Pharma Inc 984,888 bottles units
FDA Drug Class II Terminated

Cetirizine Hydrochloride Oral Solution, USP 1mg/mL, Fr Oral Use Only, Rx only, 120 mL bottle, a) NDC 13668-029-07, b) NDC 13668-596-07, Manufactured by Bio-Pharm, Inc. Levittown, PA, For Torrent Pharm

May 21, 2019 Torrent Pharma Inc 730,476 bottles units
FDA Drug Class II Terminated

Pain & Fever Oral Solution (Acetaminophen 160 mg/5 mL), Sugar free, Aspirin & Alcohol free, Cherry flavored, a) 4 Fl. oz. bottle, NDC: 0536-0122-97, b) One Pint (473 mL) bottle, NDC: 0536-0122-85, Di

May 21, 2019 Torrent Pharma Inc 1,883,796 bottles units
FDA Drug Class II Terminated

Pedia Relief Cough-Cold Oral Solution, Alcohol free, antihistamine, cough suppressant, nasal decongestant, Chlorpheniramine Maleate, USP 2 mg; Dextromethorphan HBr, USP 10 mg; Pseudoephedrine HCl, USP

May 21, 2019 Torrent Pharma Inc 17,748 bottles units
FDA Drug Class II Terminated

Bisacodyl Suppositories, Brite Stock, Reese.

May 21, 2019 Torrent Pharma Inc N/A units
FDA Drug Class II Terminated

Hyoscyamine Sulfate Elixir 0.125 mg per 5 mL, Rx Only, 473 mL (16 oz.) bottle, NDC:39328-048-16, Patrin Pharma, Skokie IL 60076.

May 21, 2019 Torrent Pharma Inc 24,384 bottles units
FDA Drug Class II Terminated

Pseudoephedrine Oral Solution, 30 mg in each teaspoonful, Nasal Decongestant, One Pint (473 mL) bottle, NDC: 0536-1850-85, Distributed by Rugby Laboratories, Livonia MI 48152.

May 21, 2019 Torrent Pharma Inc 1,436,904 bottles units
CPSC Ongoing

ION Audio Recalls Portable Speakers Due to Explosion Hazard

May 21, 2019 Shenzhen Fenda Technology Co., Ltd., China About 41,000 units
FDA Drug Class II Terminated

Guaifenesin DAC Oral Solution, Sugar free, (Guaifenesin, Pseudoephedrine HCl and Codeine Phosphate Oral Solution, USP), Expectorant, Nasal Decongestant, Cough Suppressant, 100 mg/30 mg/10 mg per 5 mL

May 21, 2019 Torrent Pharma Inc 6,000 bottles units
NHTSA Ongoing

WiFi Power Converter May Overheat

May 21, 2019 Linora Corporation 2,800 units
FDA Drug Class II Terminated

Phenobarbital Oral Solution, USP, 20 mg per 5 mL, Rx Only, One Pint (473 mL) bottle, NDC:16571-330-16, Manufactured by Bio-Pharm Inc., Levittown, PA 10957, Distributed by Rising Pharmaceuticals Inc.,

May 21, 2019 Torrent Pharma Inc 148,440 bottles units
FDA Drug Class II Terminated

Biscolax Laxative (Bisacodyl, USP 10 mg), a) 12 suppositories per carton, NDC: 0904-5058-12, b) 100 suppositories per carton, NDC: 0904-5058-60, Distributed by Major Pharmaceuticals Inc., Livonia MI 4

May 21, 2019 Torrent Pharma Inc 391,404 cartons units
FDA Drug Class II Terminated

Banophen Oral Solution, Sugar Free, Alcohol Free, Cherry Flavor, (Diphenhydramine HCl, USP) Each teaspoonful contains diphenhydramine hydrochloride, USP 12.5 mg, a) 4 Fl. oz. (118 mL) bottle, NDC: 090

May 21, 2019 Torrent Pharma Inc 655,104 bottles units
FDA Drug Class II Terminated

Children's Acetaminophen Liquid, 160 mg per 5 mL, Fever and Pain, Alcohol free, aspirin free, ibuprofen free, Cherry Flavor, 4 FL. oz. (118 mL) bottle, NDC: 59741-101-06, Manufactured by Bio-Pharm, In

May 21, 2019 Torrent Pharma Inc 58,272 bottles units
FDA Drug Class II Terminated

Children's Mapap Acetaminophen Liquid, Fever reducer, Pain reliever, Alcohol free, Aspirin free, Cherry flavored, acetaminophen 160 mg per 5 mL, a) 4 FL. oz. (118 mL) bottle, NDC 0904-1985-20, b) One

May 21, 2019 Torrent Pharma Inc 2,646,228 bottles units
FDA Drug Class II Terminated

Kid Kare Childrens Cough/Cold Liquid, Antihistamine, Cough Suppressant, Nasal Decongestant, Cherry Flavored, Alcohol Free, (Chlorpheniramine Maleate, USP 2 mg, Dextromethorphan HBr, USP 10 mg, Pseudo

May 21, 2019 Torrent Pharma Inc 66,060 bottles units
FDA Drug Class II Terminated

Memantine Hydrochloride Oral Solution, 2 mg/mL, 12 oz. bottle, NDC: 39328-551-12, Patrin Pharma

May 21, 2019 Torrent Pharma Inc 5,681 bottles units
FDA Drug Class II Terminated

Hydrocortisone Acetate Suppositories, 25 mg, Rx Only, For rectal administration, a) 12 Adult Suppositories per carton, NDC: 59741-301-12, b) 24 Adult Suppositories per carton, NDC: 59741-301-24, Manuf

May 21, 2019 Torrent Pharma Inc 140,436 suppositories units
FDA Drug Class II Terminated

Laxative Suppositories (Bisacodyl USP, 10 mg), a) 12 Suppositories per carton, NDC: 0536-1355-12, b) 100 Suppositories per carton, NDC: 0536-1355-01, Distributed Rugby Laboratories, Livonia, MI 48152.

May 21, 2019 Torrent Pharma Inc 120,204 cartons units
FDA Drug Class II Terminated

Hemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fat 88.7%), 12 Rectal Suppositories per carton, NDC: 0536-1389-12, Distributed by Rugby Laboratories, Livonia MI 48152 USA.

May 21, 2019 Torrent Pharma Inc 82,872 bottles units
FDA Drug Class II Terminated

Memantine Hydrochloride Oral Solution, 2 mg/mL, Rx Only, 12 FL. oz.. bottle, NDC: 13668-573-09, Manufactured By Bio-Pharm Inc., Levittown, PA 19057, Manufactured for Torrent Pharma Inc., Basking Ridge

May 21, 2019 Torrent Pharma Inc 264 bottles units
FDA Drug Class II Terminated

Robafen DM Cough Sugar-Free Clear Cough Expectorant (Dextromethorphan HBr, USP 20 mg), Expectorant (Guaifenesin, USP 200 mg in each 2 teaspoonfuls (10mL)), 4 Fl. oz. (118 mL) bottle, NDC: 0904-6306-20

May 21, 2019 Torrent Pharma Inc 262,008 bottles units
FDA Drug Class II Terminated

Diphenhist Oral Solution (Diphenhydramine HCl, USP), 12.5 mg/5 mL, a) 4 FL. oz. (118 mL) bottle, NDC: 0536-0770-97, b) One Pint (473 mL) bottle., NDC: 0536-0770-85, Distributed by Rugby Laboratories,

May 21, 2019 Torrent Pharma Inc 438,624 bottles units
FDA Drug Class II Terminated

Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, Rx Only, 16 FL. oz. (473 mL) bottle, NDC:13668-577-10 Distributed by Torrent Pharma Inc., Basking Ridge, NJ

May 21, 2019 Torrent Pharma Inc 7,728 bottles units
FDA Drug Class II Terminated

Cough Syrup (Guaifenesin Syrup, USP) 200 mg/10 mL, Alcohol free Non-Narcotic Expectorant, One Pint (473 mL) oz. bottle, NDC: 0536-0825-85, Distributed by Rugby Laboratories, Livonia, MI 48152.

May 21, 2019 Torrent Pharma Inc 249,744 bottles units
FDA Drug Class II Terminated

Cyproheptadine Hydrochloride Syrup Oral Solution, USP, 2mg/5mL, 473 mL (16 FL. oz.) bottle, NDC: 39328-044-16, Patrin Pharma, Skokie, IL 60076.

May 21, 2019 Torrent Pharma Inc 66,798 bottles units
FDA Drug Class II Terminated

Acetic Acid Otic Solution, USP, 2%, Rx Only, 15 mL bottle, NDC: 64980-424-15, Manufactured by Bio-Pharm Inc., Levittown, PA 19057, Distributed by Rising Pharmaceuticals Ins Saddie Brook, NJ 07663.

May 21, 2019 Torrent Pharma Inc 14,016 bottles units
FDA Drug Class II Terminated

RisperiDONE Oral Solution, USP, 1 mg/mL, Rx Only, 30 mL bottle, NDC 13668-589-06, Manufactured by Bio-Pharm Inc., Levittown PA 19057, Manufactured for Torrent Pharma Inc., Basking Ridge, NJ 07920.

May 21, 2019 Torrent Pharma Inc 48,955 bottles units
FDA Food Class I Terminated

Wegman's Neptune Salad 1 lb containers, UPC Begins with 2010883100000, Model/catalog # 13081

May 21, 2019 Wegmans Food Markets, Inc. 32 individual 1-lb units units
FDA Drug Class II Terminated

Anu-Med brand of Hemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fat 88.7%), 12 suppositories per carton, NDC: 0904-7688-22, Distributed by Major Pharmaceuticals, Livonia MI 48152.

May 21, 2019 Torrent Pharma Inc 177,408 bottles units
FDA Drug Class II Terminated

Nasal Decongestant Spray Regular, Oxymetazoline HCl 0.05%, a) 0.5 FL. oz. (15 mL) bottle, NDC:0904-5711-35, b) 1 FL. oz. (30 mL) bottle, NDC: 0904-5711-30, Distributed by Major Pharmaceuticals, Livoni

May 21, 2019 Torrent Pharma Inc 3,788,502 bottles units
FDA Drug Class II Terminated

Cetirizine HCL Oral Solution, USP 1mg/mL, 4 oz - BULK, PLD

May 21, 2019 Torrent Pharma Inc 361,260 bottles units
FDA Drug Class II Terminated

Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL, For Oral Use Only, Rx Only, 120 mL bottle, NDC 23155-292-51, Mfd for Heritage Pharmaceuticals Inc., Eatontown, NJ 07724.

May 21, 2019 Torrent Pharma Inc 1,126,404 bottles units
FDA Drug Class II Terminated

Lactulose Solution, USP 10 g/15 mL, For Oral Administration, Rx Only, a) 16 FL. oz., NDC: 13668-580-10, b) 32 FL. oz., NDC: 13668-580-12, Manufactured by Bio-Pharm Inc., Levittown PA 19057, Manufactur

May 21, 2019 Torrent Pharma Inc 96,060 bottles units
FDA Drug Class II Terminated

Robafen DM Syrup (Dextromethorphan HBr, USP 20 mg/10 mL and Guaifenesin, USP 200 mg/10 mL), a) 4 oz. bottle, NDC: 0904-0053-00, b) 8 oz. bottle, NDC: 0904-0053-09, c) 16 oz. bottle, NDC:0904-0053-16,

May 21, 2019 Torrent Pharma Inc 1,500,672 bottles units
NHTSA Ongoing

Fuel Sprays When Cap is Removed

May 21, 2019 DUCATI NORTH AMERICA 1,880 units
FDA Drug Class II Terminated

RisperiDONE Oral Solution, USP, 1 mg/mL, Rx Only, 30 mL bottle, NDC 23155-317-51, Mfd for Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816.

May 21, 2019 Torrent Pharma Inc 52,368 bottles units
FDA Drug Class II Terminated

Robafen AC Oral Solution (Guaifenesin and Codeine Phosphate Oral Solution, USP) 100 mg/10 mg per 5 mL, One Pint (473 mL) bottle, NDC:0904-6479-16, Distributed by Major Pharmaceuticals Inc., Livonia MI

May 21, 2019 Torrent Pharma Inc 131,328 bottles units
FDA Drug Class II Terminated

Extra Action Cough Syrup (Guaifenesin and Dextromethorphan HBr Syrup) 100 mg/10 mg per 5 mL, a) 4 FL. oz. (118 mL) bottle, NDC: 0536-0970-97, b) One Pint (473 mL) bottle, 0536-0970-85, Distributed by

May 21, 2019 Torrent Pharma Inc 176,580 bottles units
FDA Drug Class II Terminated

Guaifenesin AC Cough Syrup (Guaifenesin and Codeine Phosphate Oral Solution, USP) 100 mg/10 mg per 5 mL, One Pint (473 mL) bottle, NDC: 16571-302-16, Distributed by Rising Pharmaceuticals Inc., Saddle

May 21, 2019 Torrent Pharma Inc 233,388 bottles units
FDA Drug Class II Terminated

Allergy Liquid Antihistamine, Diphenhydramine HCl USP 12.5 mg/5 mL), Alcohol free, 4 FL. oz. (118 mL) bottle, NDC: 59741-119-06, Manufactured by Bio-Pharm Inc., Levittown, PA 19057, Assured.

May 21, 2019 Torrent Pharma Inc 118,080 bottles units
FDA Food Class III Terminated

Blue Plate Light Mayonnaise 30oz, PET jars

May 20, 2019 Reily Foods Co., Inc 945 cases, 12 units/case units
NHTSA Ongoing

Passenger-Side Windshield Wiper May Malfunction

May 20, 2019 NEWELL COACH CORP. 89 units
FDA Food Class II Terminated

Suja Organic Kombucha - Variety Pack: 6 x 15.2 oz. glass bottle; 2 each of Ginger Lemon, Mixes Berries and Peach Ginger UPC 818617020737; DISTRIBUTED BY SUJA LIFE, LLC OCEANSIDE, CA 92056 CERT

May 20, 2019 Suja Life LLC 31,079 cases units
FDA Food Class II Terminated

Suja Organic Kombucha - Ginger Lemon: 15.2 oz. glass bottle; UPC 818617020232 DISTRIBUTED BY SUJA LIFE, LLC OCEANSIDE, CA 92056 CERTIFIED ORGANIC BY CCOF SUJAJUICE.COM

May 20, 2019 Suja Life LLC 64,896 bottles units
FDA Food Class II Terminated

Suja Organic Kombucha - Peach Ginger: 15.2 oz. glass bottle; UPC 818617020348 DISTRIBUTED BY SUJA LIFE, LLC OCEANSIDE, CA 92056 CERTIFIED ORGANIC BY CCOF SUJAJUICE.COM

May 20, 2019 Suja Life LLC 90,489 bottles units
FDA Food Class II Terminated

Park Street Deli, Hummus and Veggies, Classic Hummus, Carrots & Celery NET WT 5 OZ (142g)

May 20, 2019 Del Monte Fresh Produce N.A., Inc. HQ 126 units units
NHTSA Ongoing

Front and Rear Frame Cracking

May 20, 2019 Entrans International LLC 769 units