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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Showing 8,641–8,660 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass 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.

by Todd Holiday dba Sunstone Organics

Reason
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
Recall initiated
February 13, 2019
Reported by FDA
March 13, 2019
Distribution
California, Nebraska, Oregon, Washington

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Drug Recall Terminated Historical recordClass 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.

by Todd Holiday dba Sunstone Organics

Reason
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
Recall initiated
February 13, 2019
Reported by FDA
March 13, 2019
Distribution
California, Nebraska, Oregon, Washington

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Drug Recall Terminated Historical recordClass 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.

by Todd Holiday dba Sunstone Organics

Reason
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
Recall initiated
February 13, 2019
Reported by FDA
March 13, 2019
Distribution
California, Nebraska, Oregon, Washington

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Drug Recall Terminated Historical recordClass 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

by Vi-Jon, Inc.

Reason
Cross Contamination: Presence of IPA in finished product.
Recall initiated
February 20, 2019
Reported by FDA
March 13, 2019
Distribution
Distributed in Ohio

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Drug Recall Terminated Historical recordClass 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

by Jubilant Cadista Pharmaceuticals, Inc.

Reason
Failed Dissolution Specifications; 9-monthstability timepoint
Recall initiated
February 28, 2019
Reported by FDA
March 13, 2019
Distribution
Product was distributed to one customer who may have further distributed the product.

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Drug Recall Terminated Historical recordClass 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.

by Leiter's Enterprises, Inc.

Reason
Incorrect Product Formulation; compounded sterile drug reconstituted using sterile water instead of sterile 0.9% Sodium Chloride.
Recall initiated
February 19, 2019
Reported by FDA
March 13, 2019
Distribution
CA, AZ, MI, NY

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Drug Recall Terminated Historical recordClass 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.

by Lupin Pharmaceuticals Inc.

Reason
Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities.
Recall initiated
February 26, 2019
Reported by FDA
March 6, 2019
Distribution
Nationwide in the USA and Puerto Rico.

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Drug Recall Terminated Historical recordClass 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

by Amerigen Pharmaceuticals Inc.

Reason
Failed dissolution specifications
Recall initiated
February 19, 2019
Reported by FDA
February 27, 2019
Distribution
Product was distributed to 4 wholesalers/distributors and 1 retail account who may have further distribute the product throughout the United States.

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Drug Recall Terminated Historical recordClass 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.

by Akorn Inc

Reason
Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study.
Recall initiated
January 25, 2019
Reported by FDA
February 27, 2019
Distribution
Nationwide, including Puerto Rico.

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Drug Recall Terminated Historical recordClass 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

by ACP Nimble Buyer, Inc.

Reason
Labeling: Not Elsewhere Classified. Mometasone Furoate Cream has an NDC typographical error.
Recall initiated
February 7, 2019
Reported by FDA
February 27, 2019
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass 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.

by Lupin Pharmaceuticals Inc.

Reason
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
Recall initiated
February 13, 2019
Reported by FDA
February 27, 2019
Distribution
Nationwide in the USA and Puerto Rico.

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Drug Recall Terminated Historical recordClass III

Ciclopirox shampoo 1%,120 mL bottle, Rx only, Manufactured By Perrigo Bronx, NY 10457 Distributed by Perrigo Allegan, MI 49010, 45802-401-09

by Perrigo New York, Inc.

Reason
Failed Degradation/Impurities Specifications: Out of specification related substance results during stability testing.
Recall initiated
February 13, 2019
Reported by FDA
February 27, 2019
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass 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.

by Akorn Inc

Reason
Failed Stability Specification: out of specification results for Sodium Perborate
Recall initiated
February 4, 2019
Reported by FDA
February 27, 2019
Distribution
Nationwide in the USA.

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Drug Recall Terminated Historical recordClass 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.

by Mariposa Labs LLC

Reason
Microbial Contamination of Non-Sterile Products: Consumer complaint and subsequent testing found lot to be out of specification for mold.
Recall initiated
November 12, 2015
Reported by FDA
February 27, 2019
Distribution
Distributed in California

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Drug Recall Terminated Historical recordClass II

0.9% Sodium Chloride Injection, USP 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-09

by ICU Medical Inc

Reason
CGMP Deviations
Recall initiated
February 4, 2019
Reported by FDA
February 27, 2019
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass 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

by US Compounding Inc

Reason
Lack of assurance of sterility.
Recall initiated
January 29, 2019
Reported by FDA
February 27, 2019
Distribution
U.S.A. Nationwide

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Drug Recall Terminated Historical recordClass 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

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Dissolution Specifications: Out of specification results observed for high dissolution.
Recall initiated
January 31, 2019
Reported by FDA
February 27, 2019
Distribution
U.S.A. Nationwide

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Drug Recall Terminated Historical recordClass 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

by Mylan Pharmaceuticals Inc.

Reason
Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stability testing
Recall initiated
February 13, 2019
Reported by FDA
February 27, 2019
Distribution
Throughout the United States

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Drug Recall Ongoing Historical recordClass 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

by Torrent Pharma Inc.

Reason
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.
Recall initiated
December 20, 2018
Reported by FDA
February 27, 2019
Distribution
Nationwide USA and Puerto Rico

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Drug Recall Ongoing Historical recordClass 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

by Torrent Pharma Inc.

Reason
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.
Recall initiated
December 20, 2018
Reported by FDA
February 27, 2019
Distribution
Nationwide USA and Puerto Rico

View recall →

Data last updated:

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.