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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
Dr. King's Natural Medicine Homeopathic Regional Allergies Great Lakes U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955519027, NDC 57955-8195-2 King Bio Inc. Class I Terminated 20190320
Dr. King's Natural Medicine Homeopathic Regional Allergies Desert U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955518822, NDC 57955-8196-2 King Bio Inc. Class I Terminated 20190320
Dr. King's Natural Medicine Homeopathic Regional Allergies Plains U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955518585, NDC 57955-8199-2 King Bio Inc. Class I Terminated 20190320
Dr. King's Natural Medicine Homeopathic Heartburn Reliever, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955502227, NDC 57955-5022-2 King Bio Inc. Class I Terminated 20190320
Dr. King's Natural Medicine Homeopathic Heart Regularity, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955506522, NDC 57955-5065-2 King Bio Inc. Class I Terminated 20190320
Dr. King's Natural Medicine Homeopathic Regional Allergies Southern U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955518426, NDC 57955-0760-2 King Bio Inc. Class I Terminated 20190320
Dr. King's Natural Medicine Homeopathic Bladder Formula, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955504528, NDC 57955-1503-2 King Bio Inc. Class I Terminated 20190320
Dr. King's Natural Medicine Homeopathic Regional Allergies Pacific U.S. 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955519324, NDC 57955-8198-2 King Bio Inc. Class I Terminated 20190320
Dr. King's Natural Medicine Homeopathic Menstrual Cramps & Irregularities 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955500421, NDC 57955-5004-02 King Bio Inc. Class I Terminated 20190320
Dr. King's Natural Medicine Homeopathic Cold Sores & Herpes, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955516521, NDC 57955-5165-2 King Bio Inc. Class I Terminated 20190320
Dr. King's Natural Medicine Homeopathic Regional Allergies Rocky Mtns. U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955518624, NDC 57955-0200-2 King Bio Inc. Class I Terminated 20190320
Dr. King's Natural Medicine Homeopathic Regional Allergies Northeastern U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955519225, NDC 57955-0753-2 King Bio Inc. Class I Terminated 20190320
Dr. King's Natural Medicine Homeopathic Male Libido, 2 fl. oz. (59 mL), King Bio, Inc. 3 Westside Dr. Asheville, NC 28806, UPC 3579555101022, NDC 57955-5510-2 King Bio Inc. Class I Terminated 20190320
Dr. King's Lymph Detox, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955506324, NDC 57955-5063-2 King Bio Inc. Class I Terminated 20190320
Dr. King's aquaflora Candida High Potency, 8 fl. oz. (236 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 35795580018, NDC 57955-8020-89 King Bio Inc. Class I Terminated 20190320
Tamsulosin Hydrochloride Capsules, USP, 0.4 mg, 500-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, INDIA; Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-450-05. Ascend Laboratories LLC Class II Terminated 20190313
ATHLETICARE Anti-Bacterial Hand Soap AC 550 (triclosan), 0.25%, 4 litres/1.1 US Gallon bottles, packaged in 4 x 4 Litres/1.1 US gallons per case, Petra Hygienic Systems, Concord, ON L4K 4RS/ Reno, NV 89511, NDC 42326-550-01, UPC 0 65936 10335 5. Petra Hygienic Systems Int Ltd Class III Terminated 20190313
Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.03 mg, 28 Tablets Blister, 1 Unit (NDC 60505-4183-1) packaged as 84 Tablets Blister, 3x1 Unit per carton (NDC 60505-4183-3), Rx Only, Manufactured for: Apotex Corp., Weston, FL 33326; Manufactured by: Oman Pharmaceutical Products Co. L.L.C., P.O. Box 1885, Postal Code 111, Seeb. Apotex Inc. Class II Completed 20190313
Maeng Da Kratom, packaged in a) 20 count capsules (UPC 00859667007149), b) 60 count capsules (UPC 00859667007156), c) 150 count capsules (UPC 00859667007163) , Sunstone Organics Springfield, Oregon 97473, 541-972-3327. Todd Holiday dba Sunstone Organics Class I Terminated 20190313
White Vein Kratom, packaged in a) 20 count capsules (UPC 00859667007347), b) 60 count capsules (UPC 00859667007354), c) 150 count capsules (UPC 00859667007361), Sunstone Organics Springfield, Oregon 97473 541-972-3327. Todd Holiday dba Sunstone Organics Class I Terminated 20190313
White Vein Kratom, packaged in a) 25 gram powder (UPC 00859667007316), b) 50 gram powder (UPC 00859667007323), c) 100 gram powder (UPC 00859667007330), Sunstone Organics Springfield, Oregon 97473, 541-972-3327. Todd Holiday dba Sunstone Organics Class I Terminated 20190313
Maeng Da Kratom, packaged in a) 25 gram powder (UPC 00859667007118), b) 50 gram powder (UPC 00859667007125), c) 100 gram powder (UPC 00859667007132), Sunstone Organics Springfield, Oregon 97473, 541-972-3327. Todd Holiday dba Sunstone Organics Class I Terminated 20190313
Topical Solution USP Hydrogen Peroxide First Aid Antiseptic Oral Debriding Agent 32 Fl. Oz. (1 QT) 946 mL bottle, Distributed By: Discount Drug Mart 211 Commerce Drive, Medina, Ohio 44256 NDC 53943-871-45 UPC 0-93351-12758-8 Vi-Jon, Inc. Class II Terminated 20190313
BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150 mg, a) 30 count (NDC 59746- 758-30) & b) 90 count (NDC 59746-758-90) bottles, Rx only, Manufactured b Jubilant Generis Ltd, Roorkee, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD Jubilant Cadista Pharmaceuticals, Inc. Class III Terminated 20190313
Cefuroxime 10 mg/mL in Sodium Chloride, Intravitreal injection, 1 mL in a 2mL Vial, Ophthalmic Use Only, Office Use Only, Leiter's (800) 292-6772- 17 Great Oaks Blvd., San Jose, CA 95119. NDC: 70360-007-35. Leiter's Enterprises, Inc. Class II Terminated 20190313
Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-422-01. Lupin Pharmaceuticals Inc. Class III Terminated 20190306
Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 43975-252-05) b) 14-count bottle (NDC 43975-252-14), Rx only, Mfd. by: Stason Pharmaceuticals, Inc., Irvine, CA 92618, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ 07071 Amerigen Pharmaceuticals Inc. Class III Terminated 20190227
Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) and b) 60 gram (NDC 50383-270-60) tubes, Rx only. Manufacturer: Akorn Inc. 369 Bayview Ave., Amityville, NY 117701. Akorn Inc Class III Terminated 20190227
Mometasone Furoate Cream, 0.1%, 45 g tube, Rx Only, Manufactured by: G&W Laboratories, Inc. South Plainfield, NJ 07080, NDC 0713-0726-37 ACP Nimble Buyer, Inc. Class III Terminated 20190227
Lovastatin Tablets USP, 40 mg, packaged in a) 60-count (NDC 68180-469-07 and b) 100-count (NDC 68180-469-01) bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Goa 403 722 INDIA. Lupin Pharmaceuticals Inc. Class III Terminated 20190227
Ciclopirox shampoo 1%,120 mL bottle, Rx only, Manufactured By Perrigo Bronx, NY 10457 Distributed by Perrigo Allegan, MI 49010, 45802-401-09 Perrigo New York, Inc. Class III Terminated 20190227
Moisturizing Lubricant Eye Drops, 0.25% Sodium Carboxymethylcellulose, 0.5 Fl OZ (15mL) Distributed by: Walgreen Co, 200 Wilmont Rd Deerfield IL 60015 NDC 00363-9651-01. Akorn Inc Class II Terminated 20190227
tubby todd Bath Co, 100% NATURAL DREAM CREAM, Shea Butter and Mint, 3.5 FL OZ 99G, Distributed by: Tubby Todd Bath Co. Vista, CA 920, (619) 894-6560. Mariposa Labs LLC Class II Terminated 20190227
0.9% Sodium Chloride Injection, USP 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-09 ICU Medical Inc Class II Terminated 20190227
Ephedrine Sulfate, 50 mg/10 mL, 10 mL Single Use Syringe, Rx only, US Compounding Pharmacy 1270 Don's Lane Conway, AR 800-718-3588, Barcode: 62295308407 US Compounding Inc Class II Terminated 20190227
Divalproex Sodium Extended-release Tablets, USP 250 mg, 100-count bottle, Rx only, Mfd.By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India NDC 55111-533-01 Dr. Reddy's Laboratories, Inc. Class II Terminated 20190227
Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count bottles (NDC 0378-5280-01), and b) 500-count bottles (NDC 0378-5280-05), Rx only, Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV, 26505 Mylan Pharmaceuticals Inc. Class III Terminated 20190227
LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP 50 mg/12.5 mg, a) 90-count bottle (NDC: 13668-116-90), b) 1000-count bottle (NDC: 13668-116-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda Torrent Pharma Inc. Class II Ongoing 20190227
LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP, 100 mg/12.5 mg, a) 90-count bottle (NDC: 13668-117-90), b) 1000-count bottle (NDC: 13668-117-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda Torrent Pharma Inc. Class II Ongoing 20190227
LOSARTAN POTASSIUM TABLETS, USP, 25 mg, 90-count bottle (NDC: 13668-113-90), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda Torrent Pharma Inc. Class II Ongoing 20190227
LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count bottle (NDC: 13668-409-30), b) 90-count bottle (NDC: 13668-409-90), c) 1000-count bottle (NDC: 13668-409-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda Torrent Pharma Inc. Class II Ongoing 20190227
LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 30-count (NDC: 13668-115-30), b) 90-count (NDC: 13668-115-90), c) 1000-count (NDC: 13668-115-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda Torrent Pharma Inc. Class II Ongoing 20190227
Oxytocin 30 Units added to NS 500 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 503 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-706-50. Advanced Pharma Inc. Class III Terminated 20190227
Oxytocin 20 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1002 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-703-99. Advanced Pharma Inc. Class III Terminated 20190227
Oxytocin 10 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1001 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-730-99. Advanced Pharma Inc. Class III Terminated 20190227
Fentanyl in 0.9% Sodium Chloride QS 0.5 mL, 5 mcg/0.5 mL with up to 0.1 mL of overfill Injectable Solution, Sterile single use syringe, Rx only, Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404, NDC 42852-210-72 Advanced Pharma Inc. Class II Terminated 20190227
MAGnesium 2 gm sulfate, added to NS 50 mL, Sterile single use bag, 54 mL, Compounded by Avella Specialty Pharmacy 24416 N 19 th Avenue, Phoenix, AZ 85085 (877) 794-0404, NDC 42852-907-05. Avella of Deer Valley, Inc. Store 38 Class II Terminated 20190220
MAGnesium 2gm sulfate, added to D5W 50 mL, Volume: 54 mL, Sterile single use bag, Compounded by Avella Specialty Pharmacy 24416 N 19th Avenue, Phoenix, AZ 85085 (877) 794-0404, NDC 42852-902-05. Avella of Deer Valley, Inc. Store 38 Class II Terminated 20190220
MAGnesium 1gm sulfate, added to D5W 50 mL, Volume 52 mL, sterile single use bag, Compounded by Avella Specialty Pharmacy 24416 N 19th Avenue, Phoenix, AZ 85085 (877) 794-0404, NDC 42852-901-05. Avella of Deer Valley, Inc. Store 38 Class II Terminated 20190220
Labetalol 20mg, HCL, USP Injectable Solution, 20mg/4mL (5 mg per mL), 4mL single use syringe. Repackaged by Avella Specialty Pharmacy 24416 N 19th Avenue, Phoenix, AZ 85085 (877) 794-0404, NDC 42852-822-71. Avella of Deer Valley, Inc. Store 38 Class II Terminated 20190220