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FDA Drug Recalls

18043 recall notices on file. Class I recalls involve a reasonable probability of serious adverse health consequences or death.

ProductFirmClassificationStatusReport date
Clopidogrel Tablets, USP, 75 mg, 500-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceutical Ltd., Baddi, Himachal, Pradesh, INDIA NDC 33342-060-15 Macleods Pharma Usa Inc Class II Terminated 20210908
Artificial Tears Ointment, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-062-35 Akorn, Inc. Class II Terminated 20210908
Lidocaine Ointment USP, 5% Rx Only, Net Wt 35.44 g(1 1/4 oz)packaged in a laminat tube, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-008-14. Teligent Pharma, Inc. Class III Terminated 20210908
Donepezil HCL Tablets, USP, 5 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801 NDC 59746-329-90 Jubilant Cadista Pharmaceuticals, Inc. Class III Terminated 20210908
MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8 Fl OZ (236 mL) bottle, Manufactured by Asiaticon, S.A. de C.V. Conkal 62, Jardines del Ajusco, Tlalpan, Ciudad de Mexico, C.P. 14200. Distributed by SBL Brands, LLC Las Vegas, NV 89119 UPC: 6 76753 00420 8 , Global Sanitizers LLC Class II Ongoing 20210908
MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8.5 FL OZ / 250 mL bottle, Made in Mexico, Distributed by SBL Brands, LLC Las Vegas, NV 89119. UPC: 6 76753 00359 1 , Global Sanitizers LLC Class II Ongoing 20210908
MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8.5 FL OZ / 250 mL bottle, Made in Mexico, Distributed by SBL Brands, LLC Las Vegas, NV 89119. UPC: 6 76753 00359 1 Global Sanitizers LLC Class I Ongoing 20210908
MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8 FL OZ (236 mL) bottle, Manufactured by Asiaticon, S.A. de C.V. Conkal 62, Jardines del Ajusco, Tlalpan, Ciudad de Mexico, C.P. 14200, Distributed by SBL Brands, LLC. Las Vegas, NV 89119. Made in Mexico UPC: 6 76753 00420 8, Global Sanitizers LLC Class I Ongoing 20210908
MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8.5 FL OZ (250 mL) bottle, Manufactured by Asiaticon, S.A. de C.V. Conkal 62, Jardines del Ajusco, Tlalpan, Ciudad de Mexico, C.P. 14200, Distributed by SBL Brands, LLC. Las Vegas, NV 89119. Made in Mexico UPC 6 76753 00414 7 Global Sanitizers LLC Class II Ongoing 20210908
MEDICALLY MINDED ANTIMICROBIAL Hand Sanitizer Gel with Aloe Vera, (Ethyl Alcohol 70% v/v), 10 FL OZ / 300 mL, Manufactured by Grupo V-Klean S.A. de C.V, Calle Alborada 124, Parques del Pedregal, Tlalpan, 14250 Ciudad de Mexico, CDMX, Distributed by SBL Brands, LLC. Las Vegas, NV 89119. Made in Mexico UPC: 6 76753 00417 8 Global Sanitizers LLC Class II Ongoing 20210908
Naproxen Sodum Tablets USP 220 mg, (Caplet), Manufactured by: Granules India Limited, Sy.No. 160/A, 161/E, 162, &174/A, Gagillapur Village, Dundigal-Gandimalsamma Monday, Medchai-Maikhajgir District - 500043, Telangana, INDIA. NDC 62207-762-36 Granules USA, Inc. Class II Terminated 20210908
Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, NDC 57237-266-01 Teva Pharmaceuticals USA Class II Terminated 20210908
Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, NDC 70199-014-01 Teva Pharmaceuticals USA Class II Terminated 20210908
Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3330-01 Teva Pharmaceuticals USA Class II Terminated 20210908
Trulicity (dulaglutide), 0.75 mg/0.5 mL, 4 Single-Dose Pens per box, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 0002-1433-80 Eli Lilly & Company Class II Terminated 20210901
Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA 18940, NDC 10702-223-21. KVK-Tech, Inc. Class I Terminated 20210901
Bleomycin for Injection, USP, packaged in 15 units per single dose vial, Rx only, Manufactured by Thymoorgan Pharmazie GmbH Schiffgraben 23, 38690 Gosfar, Germany Distributed by Hikma USA Inc. Berkeley Heights, NJ 07922, NDC 0143-9240-01 Hikma Pharmaceuticals USA Inc. Class III Terminated 20210901
Miss Slim, capsules, packaged in 10-count and 30-count box, Distributed by : His Enterprise Made in USA UPC 742137605030 HIS ENTERPRISE INC Class II Ongoing 20210901
Erythromycin Topical Solution USP, 2%, 60mL bottle, Rx only, Teligent Pharma, Inc. Buena, NJ 08310, NDC 52565-027-59 Teligent Pharma, Inc. Class II Ongoing 20210901
Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903 SterRx, LLC Class II Terminated 20210901
Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903 NDC 70324-326-01 SterRx, LLC Class I Terminated 20210901
Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC Bensalem, PA 19020 NDC 42794-086-14 UPC Code# 3 42794 086 14 4 SigmaPharm Laboratories LLC Class II Terminated 20210901
FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, Rx Only, Mfd for: Leucadia Pharmaceuticals Carlsbad, CA 92011 U.S.A, NDC 24201-237-01 Custopharm, Inc. Class II Terminated 20210901
PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabstick, (1's), Step 1, packaged as a) Step 1 Scrub, 1 Swabstick, NDC 10819-3891-1, b) Step 2 Prep, 1 Swabstick, NDC 10819-3890-1, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S23125, UPC (01)00318019000161 Professional Disposables International, Inc Class II Terminated 20210901
PDI Povidone-Iodide Cleansing Scrub Swabstick (3's), 3 Swabsticks, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376, Reorder No S82125, NDC 10819-3891-3, UPC (01)00310819000208. Professional Disposables International, Inc Class II Terminated 20210901
PDI Povidone-Iodine Cleansing Scrub Swabstick (1's), 1 Swabstick, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S48050, NDC 10819-3891-2, UPC (01)00310819000192. Professional Disposables International, Inc Class II Terminated 20210901
PDI Povidone-Iodine Swabstick (3's), 3 Swabsticks, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S41125 NDC 10819-3885-2, UPC (01)00310819000185 Professional Disposables International, Inc Class II Terminated 20210901
PDI Povidine Iodine Swabstick (1's), 1 swabstick, Professional Disposable International, Inc. Orangeburg, NY 10962 -1376 Reorder No S41350 NDC 10819-3885-1, UPC (01)00310819000178. Professional Disposables International, Inc Class II Terminated 20210901
PDI Povidone-Iodine Prep Pad Large, 1 Prep Pad, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 USA Reorder No C12400 NDC 10819-3883-3, UPC (01)00310819000154 Professional Disposables International, Inc Class II Terminated 20210901
PDI Povidone-Iodine Prep Pad MEDIUM, 1 Prep Pad [2.0x2.5 in (5.1x6.4 cm)], Professional Disposables International Inc., Orangeburg, NY 10962-1376 Reorder No. B40600; UPC (01)00310819000147, NDC 10819-3883-1, Professional Disposables International, Inc Class II Terminated 20210901
Micafungin for Injection, 100 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089. NDC 70594-037-01 XELLIA PHARMACEUTICALS USA, LLC Class II Terminated 20210901
Micafungin for Injection, 50 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089. NDC 70594-036-01 XELLIA PHARMACEUTICALS USA, LLC Class II Terminated 20210901
Pi yen chin Ophthalmic Redness Reliever Drops Made in China, Net Wt.: 10 ml (0.34 fl/oz) Exclusive U.S. Distributor: (Chinese writing)International Nature Nutraceuticals, Inc. New York, NY 10002 www.INNHERB.com. Konzon NDC 51367-008-10 ANHUI WELCOME FOREIGN TRADE CO.,LTD. Class II Terminated 20210901
Carvedilol 25 mg, 180-count bottle, Rx only, Manufactured by Zydus Pharm, Pennington, NJ 08534, NDC 68382-0095-05, Repackaged by RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1826-01 RemedyRepack Inc. Class II Terminated 20210901
Carvedilol Tablets, USP 25 mg, 500 Tablets bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 0853, NDC 68382-095-05 Zydus Pharmaceuticals (USA) Inc Class II Terminated 20210825
Triamcinolone Acetonide Ointment USP, 0.1% 80 g cartons, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-014-80 ; packaged in tubes. Teligent Pharma, Inc. Class II Terminated 20210825
Econazole Nitrate Cream 1%, 85 grams bulk shippers, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-022-85 ; packaged in tubes. Teligent Pharma, Inc. Class II Terminated 20210825
Tizanidine HCl Tablets, USP 4 mg, 150-count bottles, Rx only, Mfd By: Dr. Reddy's Laboratories limited, Srikakulam District, 532 409 INDIA, NDC 55111-180-15. Dr. Reddy's Laboratories, Inc. Class II Terminated 20210825
Adenosine Injection, USP, 60mg/20 mL (3 mg/mL), 20 mL single-dose vial, Rx only, Mfd in the USA for: NorthStar Rx LLC Memphis, TN 38141, NDC 16714-180-01 Teva Pharmaceuticals USA Class II Terminated 20210825
Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Manufactured by: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-5145-91 Teva Pharmaceuticals USA Class II Terminated 20210825
Leucovorin Calcium for Injection, USP 100 mg/vial, 10 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-5140-01 Teva Pharmaceuticals USA Class II Terminated 20210825
Octreotide Acetate Injection 50 mcg/mL, 1 mL single-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3301-01 Teva Pharmaceuticals USA Class II Terminated 20210825
Octreotide Acetate Injection 100 mcg/mL, 1 mL single-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3311-01 Teva Pharmaceuticals USA Class II Terminated 20210825
Methylprednisolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0051-01), and b) 5mL Multi Dose Vials (NDC 0703-0063-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454. Teva Pharmaceuticals USA Class II Terminated 20210825
Alprostadil Injection USP, 500 mg/mL, 1 mL single dose, vials, 5 mL single use vial per carton (NDC 0703-1501-02), Rx only, Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054, Vial NDC 0703-1501-01 Teva Pharmaceuticals USA Class II Terminated 20210825
Metoclopramide Injection USP, 10 mg/2mL (5 mg/mL) 2 mL single-use vial, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-4502-01 Teva Pharmaceuticals USA Class II Terminated 20210825
Adenosine Injection, USP, 60mg/20mL (3 mg/mL), 20 mL single-dose vial, Rx only, Manufactured by: Teva Pharmaceuticals USA Inc. Parsippany, NJ 07054, NDC 0703-8776-01 Teva Pharmaceuticals USA Class II Terminated 20210825
Norepinephrine Bitartrate Injection, USP 4 mg/4 mL, 4 mL single dose vials, packaged in 10 vial cartons (NDC 0703-1153-03) Rx only, Teva Pharmaceuticals USA Inc. North Wales, PA 19454, vial NDC 0703-1153-01 Teva Pharmaceuticals USA Class II Terminated 20210825
Epoprostenol Sodium for Injection, 1.5 mg/vial, 10 mL vials, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-1995-01 Teva Pharmaceuticals USA Class II Terminated 20210825
Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-5145-01 Teva Pharmaceuticals USA Class II Terminated 20210825