Drug and pharmaceutical recalls

17728 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.

2019-03-13FDA-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.
2019-02-27FDA-DrugLupin Pharmaceuticals Inc.Class III
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.
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
2019-02-27FDA-DrugPerrigo New York, Inc.Class III
Ciclopirox shampoo 1%,120 mL bottle, Rx only, Manufactured By Perrigo Bronx, NY 10457 Distributed by Perrigo Allegan, MI 49010, 45802-401-09
Failed Degradation/Impurities Specifications: Out of specification related substance results during stability testing.
2019-02-27FDA-DrugAkorn IncClass II
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.
Failed Stability Specification: out of specification results for Sodium Perborate
2019-02-27FDA-DrugMariposa Labs LLCClass II
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.
Microbial Contamination of Non-Sterile Products: Consumer complaint and subsequent testing found lot to be out of specification for mold.
2019-02-27FDA-DrugICU Medical IncClass II
0.9% Sodium Chloride Injection, USP 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-09
CGMP Deviations
2019-02-27FDA-DrugUS Compounding IncClass II
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
Lack of assurance of sterility.
2019-02-27FDA-DrugDr. Reddy's Laboratories, Inc.Class II
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
Failed Dissolution Specifications: Out of specification results observed for high dissolution.
2019-02-27FDA-DrugMylan Pharmaceuticals Inc.Class III
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
Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stability testing
2019-02-27FDA-DrugTorrent Pharma Inc.Class II
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
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
2019-02-27FDA-DrugTorrent Pharma Inc.Class II
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
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
2019-02-27FDA-DrugTorrent Pharma Inc.Class II
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
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
2019-02-27FDA-DrugTorrent Pharma Inc.Class II
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
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
2019-02-27FDA-DrugTorrent Pharma Inc.Class II
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
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
2019-02-27FDA-DrugAdvanced Pharma Inc.Class III
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.
Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
2019-02-27FDA-DrugAdvanced Pharma Inc.Class III
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.
Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
2019-02-27FDA-DrugAdvanced Pharma Inc.Class III
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.
Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.

← prevpage 281/591next →

Get notified about new drug recalls

Free weekly digest. We email when a new federal recall in this category — or anything else affecting your household — is published.

Get the Sunday Brief

Get notified about new drug recalls

Explore other recall topics