DL DrugLabelsHubFDA Drug Label Lookup

FDA Drug Recalls

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

ProductFirmClassificationStatusReport date
Brimonidine Tartrate Opthalmic Solution 0.2%, 15 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-233-01 SOMERSET THERAPEUTICS LLC Class III Terminated 20200715
Brimonidine Tartrate Opthalmic Solution 0.2%, 10 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-232-01 SOMERSET THERAPEUTICS LLC Class III Terminated 20200715
Brimonidine Tartrate Opthalmic Solution 0.2%, 5 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-231-01 SOMERSET THERAPEUTICS LLC Class III Terminated 20200715
Zilretta (triamcinolone acetonide extended-release injectable suspension), 32mg per vial, 5mL vials, Single-dose Kits, Rx Only, Manufactured for: Flexion Therapeutics, Inc. 10 Mall Road, Suite 301, Burlington, MA 01803, NDC 70801-003-01 Flexion Therapeutics, Inc. Class III Terminated 20200708
Metformin HCl Extended Release Tablets, USP, 500 mg, Generic for Glucophage XR, Pkg Size 100, Mfg: Time-Cap, Labs Inc., Farmingdale, NY, Preferred Pharmaceuticals, Anaheim, CA NDC: 68788-6932-01 Preferred Pharmaceuticals, Inc. Class II Terminated 20200708
Minoxidil/Biotin/Spironolactone 1.25/5/25 mg capsule, 90 capsules per bottle, This is a compounded drug not for resale, Store at room temperature, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419. MasterPharm LLC Class I Terminated 20200708
Childrens Dimetapp Cold & Cough, For ages 6 yrs. & over, 8 FL OZ. bottle, (237 mL), Distributed by: Pfizer Madison, NJ 07940, Made in Canada, UPC: 60300312234196, NDC: 0031-2234-19. Glaxosmithkline Consumer Healthcare Holdings Class II Terminated 20200708
Childrens Robitussin Honey Cough and Chest Congestion DM, dextromethorphan (cough suppressant), guaifenesin (expectorant), 4 FL OZ. bottle (118 mL), Distributed by: Pfizer, Madison, NJ 07940 USA, UPC: 50300318760128, NDC: 0031-8760-12. Glaxosmithkline Consumer Healthcare Holdings Class II Terminated 20200708
Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets (10 x 10) unit dose cartons, Rx only, Manufactured by: Apotex, Inc., Toronto, Ontario, Canada, Manufactured for: Apotex Corp. Weston, FL, Distributed by: Major Pharmaceuticals, Livonia, MI 48152 NDC 00904-5794-61 The Harvard Drug Group Class II Terminated 20200708
Koala Hand Sanitizer, Unscented, 16 FL OZ., Antibacterial, (Ethyl Alcohol 70%), Manufactured by Beaming White LLC, 1205 NE 95th St., Vancouver, WA 98665 Beaming White Llc Class II Terminated 20200708
Koala Hand Sanitizer, Menthol, 16 FL OZ., Antibacterial, (Ethyl Alcohol 69%), Manufactured by Beaming White LLC, 1205 NE 95th St., Vancouver, WA 98665 Beaming White Llc Class II Terminated 20200708
Koala Hand Sanitizer, Soothing Eucalyptus, 16 FL OZ., Antibacterial, (Ethyl Alcohol 68%), Manufactured by Beaming White LLC, 1205 NE 95th St., Vancouver, WA 98665 Beaming White Llc Class II Terminated 20200708
amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-90 Amneal Pharmaceuticals of New York, LLC Class II Ongoing 20200701
Nabumetone Tablets, USP, 500 mg, 100 Tablets per carton (10 tablets x 10 blister cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC carton: 60687-374-01, NDC unit dose: 60687-374-11 American Health Packaging Class III Terminated 20200701
Clozapine Tablets USP tablet, 100mg, 500-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, Made in India, NDC 65862-846-05 Aurobindo Pharma USA Inc. Class II Terminated 20200701
Timolol Maleate Sterile Opthalmic Solution,USP 0.25%, 5 mL, Rx Only, For Topical Application, Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07863, Manufactured by: FDC Limited B-8, MDC Industrial Area, Waluj, Aurangabad - 431-136 Maharashtra, India, NDC 64980-513-05 Rising Pharmaceuticals, Inc. Class III Terminated 20200701
Timolol Maleate USP, 0.5%, 5 mL, Sterile Opthalmic Solution, Rx Only, For Topical Application in the Eye, Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07663, Manufactured by: FDC Limited B-8, MIDC Industrial Area, Waluj, Aurangbad - 431 136 Marahastra, India, NDC 64980-514-05 Rising Pharmaceuticals, Inc. Class III Terminated 20200701
Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets, USP 500 mg Rx Only 100 Tablets bottles, Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA Manufactured by: Marksans Pharma Ltd. Plot No, L-82, L-83, Verna Intl. Estate, Verna, Goa-403 722, India NDC 49483-623-01 Marksans Pharma Limited Class II Terminated 20200701
amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0179-BULK Amneal Pharmaceuticals of New York, LLC Class II Ongoing 20200701
amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-0178-11 Amneal Pharmaceuticals of New York, LLC Class II Ongoing 20200701
amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-10 Amneal Pharmaceuticals of New York, LLC Class II Ongoing 20200701
amneal Metformin Hydrochloride Extended-Release Tablets, 500 mg USP, 500 tablets bottles, Rx only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-05 Amneal Pharmaceuticals of New York, LLC Class II Ongoing 20200701
amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-BULK Amneal Pharmaceuticals of New York, LLC Class II Ongoing 20200701
amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-179-10 Amneal Pharmaceuticals of New York, LLC Class II Ongoing 20200701
amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg Rx only 100 Tablets bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0179-01 Amneal Pharmaceuticals of New York, LLC Class II Ongoing 20200701
amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 382213 India Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-178-10 Amneal Pharmaceuticals of New York, LLC Class II Ongoing 20200701
amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx Only, 500 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-178-50 Amneal Pharmaceuticals of New York, LLC Class II Ongoing 20200701
amneal Metformin Hydrochloride Extended-release Tablets, USP 500 mg Rx Only 90 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08907 NDC 65162-178-09 Amneal Pharmaceuticals of New York, LLC Class II Ongoing 20200701
amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, Rx Only, 100 count bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-01 Amneal Pharmaceuticals of New York, LLC Class II Ongoing 20200701
Duavee (conjugated estrogens/bazedoxifene) tablets 0.45/20 mg, packaged in 2 blister cards containing 15 tablets each (30 tablets), Rx Only, Distributed by Wyeth Pharmaceuticals LLC A subsidiary of Pfizer In Philadelphia, PA 19101 Made in Ireland, NDC 00008-1123-12 Pfizer Inc. Class III Terminated 20200701
Aripiprazole Tablets, USP, 2 mg, 30 Tablets per bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav 389350, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807 USA, NDC 62332-097-30. Alembic Pharmaceuticals Limited Class II Terminated 20200701
Nystatin Cream, USP 100,000 units per gram, 15 grams, Rx Only, Manufactured and Distributed by: Crown Laboratories, Inc. Johnson City, TN 37604, NDC 0316-0221-15 Crown Laboratories Class II Terminated 20200701
Nystatin Cream, USP 100,000 units per gram, 30 grams, Rx Only, Manufactured and Distributed by: Crown Laboratories, Inc. Johnson City, TN 37604, NDC 0316-0221-30 Crown Laboratories Class II Terminated 20200701
Soft Whisper by Powerstick Dandruff Shampoo (Pyrithione Zinc), 14.4 FL OZ. (426 mL), A.P. Deauville LLC New Brunswick, NJ 08901, NDC 42913-020-00, UPC 815195014097 A.P. Deauville, LLC Class II Terminated 20200701
R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) in Sodium Chloride solution 50 mL in 60 mL Syringe, Compounded by QuVa 519 Bloombury, NJ 08804, NDC 70092143350 QuVa Pharma, Inc. Class III Terminated 20200701
Metformin Hydrochloride Extended-release Tablets USP, 500 mg, 60 count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD Manufactured by: Lupin Limited Goa INDIA (NDC 68180-336-07) Lupin Pharmaceuticals Inc. Class II Terminated 20200701
metFORMIN HCL ER 500 mg, a) 30 tablets (NDC 72789-009-30); b) 60 tablets (NDC 72789-009-60); c) 90 tablets (NDC 72789-009-90); d) 180 tablets (NDC 72789-009-93); e) 100 tablets (NDC 49483-0623-01) bottles, Rx only PD-Rx Pharmaceuticals Incorporated, Oklahoma City, OK 73127 PD-Rx Pharmaceuticals, Inc. Class II Terminated 20200701
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, a) 100 (NDC 62037-577-01) and b) 1000 (NDC 62037-577-10), Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa, Distributed by: Actavis Pharma, Inc., Parsippany, NJ Teva Pharmaceuticals USA Class II Terminated 20200701
Metformin Hydrochloride Extended - Release Tablets, USP, 500 mg, a) 100 (NDC 62037-571-01) and b) 1,000 (NDC 62037-571-10) count bottles, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa, Distributed by: Actavis Pharma, Inc., Parsippany, NJ Teva Pharmaceuticals USA Class II Terminated 20200701
Sterile Curcumin 50mg/mL, 10 mL vial BIOTA Biosciences LLC Class II Terminated 20200701
Sterile Cannabidiol (CBD) + Curcumin 50mg/mL, 10 mL vial BIOTA Biosciences LLC Class II Terminated 20200701
Sterile Cannabidiol (CBD) 50mg/mL, 10mL vial BIOTA Biosciences LLC Class II Terminated 20200701
Sterile Curcumin, 4mg/mL, 10mL vial BIOTA Biosciences LLC Class II Terminated 20200701
Sterile Cannabidiol (CBD) 4mg/mL, 10mL vial BIOTA Biosciences LLC Class II Terminated 20200701
Gaviscon Liquid Antacid Extra Strength, Cool Mint, 12 FL OZ (355 mL) single pack and twin pack, Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0095-41 Glaxosmithkline Consumer Healthcare Holdings Class II Terminated 20200624
Gaviscon Extra Strength Liquid Antacid Extra Strength Cherry, 12 FL OZ. (355 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0574-41 Glaxosmithkline Consumer Healthcare Holdings Class II Terminated 20200624
Gaviscon Regular Strength Liquid Antacid Cool Mint, 12 FL OZ (355 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0094-41 Glaxosmithkline Consumer Healthcare Holdings Class II Terminated 20200624
Gaviscon Regular Strength Liquid Antacid Cool Mint, 6 FL OZ (177 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0094-42 Glaxosmithkline Consumer Healthcare Holdings Class II Terminated 20200624
Olanzapine Tablets, USP 7.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810, NDC 66993-682-30 Aurobindo Pharma USA Inc. Class III Terminated 20200624
Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810, NDC 66993-680-30 Aurobindo Pharma USA Inc. Class III Terminated 20200624