Drug and pharmaceutical recalls

17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.

2019-03-20FDA-DrugKing Bio Inc.Class I
Dr. King's Natural Medicine Homeopathic Regional Allergies Southwestern U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955518921, NDC 57955-8202-2
Microbial contamination
2019-03-20FDA-DrugKing Bio Inc.Class I
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
Microbial contamination
2019-03-20FDA-DrugKing Bio Inc.Class I
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
Microbial contamination
2019-03-20FDA-DrugKing Bio Inc.Class I
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
Microbial contamination
2019-03-20FDA-DrugKing Bio Inc.Class I
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
Microbial contamination
2019-03-20FDA-DrugKing Bio Inc.Class I
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
Microbial contamination
2019-03-20FDA-DrugKing Bio Inc.Class I
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
Microbial contamination
2019-03-20FDA-DrugKing Bio Inc.Class I
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
Microbial contamination
2019-03-20FDA-DrugKing Bio Inc.Class I
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
Microbial contamination
2019-03-20FDA-DrugKing Bio Inc.Class I
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
Microbial contamination
2019-03-20FDA-DrugKing Bio Inc.Class I
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
Microbial contamination
2019-03-20FDA-DrugKing Bio Inc.Class I
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
Microbial contamination
2019-03-20FDA-DrugKing Bio Inc.Class I
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
Microbial contamination
2019-03-20FDA-DrugKing Bio Inc.Class I
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
Microbial contamination
2019-03-20FDA-DrugKing Bio Inc.Class I
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
Microbial contamination
2019-03-20FDA-DrugKing Bio Inc.Class I
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
Microbial contamination
2019-03-13FDA-DrugAscend Laboratories LLCClass II
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.
Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed during stability testing.
2019-03-13FDA-DrugPetra Hygienic Systems Int LtdClass III
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.
Does Not Meet Monograph: product contains, triclosan, an ingredient that can no longer be contained in over-the-counter consumer antiseptic/antibacterial wash products.
2019-03-13FDA-DrugApotex Inc.Class II
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.
Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement.
2019-03-13FDA-DrugTodd Holiday dba Sunstone OrganicsClass I
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.
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
2019-03-13FDA-DrugTodd Holiday dba Sunstone OrganicsClass I
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.
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
2019-03-13FDA-DrugTodd Holiday dba Sunstone OrganicsClass I
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.
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
2019-03-13FDA-DrugTodd Holiday dba Sunstone OrganicsClass I
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.
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
2019-03-13FDA-DrugVi-Jon, Inc.Class II
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
Cross Contamination: Presence of IPA in finished product.
2019-03-13FDA-DrugJubilant Cadista Pharmaceuticals, Inc.Class III
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
Failed Dissolution Specifications; 9-monthstability timepoint
2019-03-13FDA-DrugLeiter's Enterprises, Inc.Class II
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.
Incorrect Product Formulation; compounded sterile drug reconstituted using sterile water instead of sterile 0.9% Sodium Chloride.
2019-03-06FDA-DrugLupin Pharmaceuticals Inc.Class III
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.
Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities.
2019-02-27FDA-DrugAmerigen Pharmaceuticals Inc.Class III
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
Failed dissolution specifications
2019-02-27FDA-DrugAkorn IncClass III
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.
Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study.
2019-02-27FDA-DrugACP Nimble Buyer, Inc.Class III
Mometasone Furoate Cream, 0.1%, 45 g tube, Rx Only, Manufactured by: G&W Laboratories, Inc. South Plainfield, NJ 07080, NDC 0713-0726-37
Labeling: Not Elsewhere Classified. Mometasone Furoate Cream has an NDC typographical error.

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