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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 3,621–3,640 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

Ketamine HCl Injection, USP, 50 mg/5 mL (10 mg/mL*) syringes, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-982-55

by Nephron Sterile Compounding Center LLC

Reason
Lack of Assurance of Sterility
Recall initiated
June 30, 2022
Reported by FDA
July 27, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

HYDROmorphone HCl Injection, USP, 50 mg/50 mL (1 mg/mL) syringes, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-559-50

by Nephron Sterile Compounding Center LLC

Reason
Lack of Assurance of Sterility
Recall initiated
June 30, 2022
Reported by FDA
July 27, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

HYDROmorphone HCl Injection, USP 30 mg/30 mL (1 mg/mL) syringe, 5 x 30 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-559-30

by Nephron Sterile Compounding Center LLC

Reason
Lack of Assurance of Sterility
Recall initiated
June 30, 2022
Reported by FDA
July 27, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

HYDROmorphone HCl Injection, USP, 6 mg/30 mL (0.2 mg/mL) syringes, 5 x 30 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-529-30

by Nephron Sterile Compounding Center LLC

Reason
Lack of Assurance of Sterility
Recall initiated
June 30, 2022
Reported by FDA
July 27, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

HYDROmorphone HCl Injection, USP, 10 mg/50 mL (0.2 mg/mL) syringes, 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia SC 29172, NDC: 69374-529-50

by Nephron Sterile Compounding Center LLC

Reason
Lack of Assurance of Sterility
Recall initiated
June 30, 2022
Reported by FDA
July 27, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Glycopyrrolate Injection, USP, 0.6 mg/3 mL (0.2 mg/mL) syringes, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-903-30

by Nephron Sterile Compounding Center LLC

Reason
Lack of Assurance of Sterility
Recall initiated
June 30, 2022
Reported by FDA
July 27, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Glycopyrrolate Injection, USP, 1 mg/5 mL (0.2 mg/mL) syringes, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-903-05

by Nephron Sterile Compounding Center LLC

Reason
Lack of Assurance of Sterility
Recall initiated
June 30, 2022
Reported by FDA
July 27, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 mcg/mL*) bags, packaged as 10 x 1 IV bag per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-523-21

by Nephron Sterile Compounding Center LLC

Reason
Lack of Assurance of Sterility
Recall initiated
June 30, 2022
Reported by FDA
July 27, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

EPINEPHrine Injection, USP, 1 mg/10 mL (100 mcg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-925-10

by Nephron Sterile Compounding Center LLC

Reason
Lack of Assurance of Sterility
Recall initiated
June 30, 2022
Reported by FDA
July 27, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

EPINEPHrine Injection, USP, 0.1 mg/10 mL (10 mcg/mL) syringes, 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia SC 29172, NDC: 69374-544-10

by Nephron Sterile Compounding Center LLC

Reason
Lack of Assurance of Sterility
Recall initiated
June 30, 2022
Reported by FDA
July 27, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Bupivacaine HCl 150 mg (3.0 mg/mL), Ketorolac Tromethamine 60 mg (1.2 mg/mL), Ketamine HCl 60 mg (1.2 mg/mL) Injection, 50 mL syringes, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-514-50

by Nephron Sterile Compounding Center LLC

Reason
Lack of Assurance of Sterility
Recall initiated
June 30, 2022
Reported by FDA
July 27, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate), 45 mg/5 mL (9 mg/mL) syringes, packaged in 5 x 5 mL Prefilled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-947-50

by Nephron Sterile Compounding Center LLC

Reason
Lack of Assurance of Sterility
Recall initiated
June 30, 2022
Reported by FDA
July 27, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

0.125% Bupivacaine HCl Injection, USP, 62.5 mg/50 mL (1.25 mg/mL) syringes, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Ext., West Columbia, SC 29172, NDC: 69374-970-50

by Nephron Sterile Compounding Center LLC

Reason
Lack of Assurance of Sterility
Recall initiated
June 30, 2022
Reported by FDA
July 27, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Atropine Sulfate Injection, USP 1.2 mg/3 mL (0.4 mg/mL) syringe, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility 4500 12th Street Extension, West Columbia, SC 29172, NDC: 69374-935-03

by Nephron Sterile Compounding Center LLC

Reason
Lack of Assurance of Sterility
Recall initiated
June 30, 2022
Reported by FDA
July 27, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Amino Acid Injection 50 g/1000 mL (50 mg/mL) bags, Rx Only, Nephron 503B outsourcing facility, 4500 12th Extension, West Columbia, SC 29172, NDC: 69374-988-10

by Nephron Sterile Compounding Center LLC

Reason
Lack of Assurance of Sterility
Recall initiated
June 30, 2022
Reported by FDA
July 27, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Hydrogen Peroxide Topical Solution USP, 3%, 16 FL OZ (1 PT) 473 mL bottle, packaged as a) Signature Care NDC 21130-871-43 UPC 3 21130-78060 1 Distributed By Better Living Brands LLC P.O. Box 99, Pleasanton, CA 94566-0009; b) Solimo UPC 8 42379 14781 4 Distributed By: Amazon.com Services, Inc. Seattle, WA 98109; c) QC Quality Choice UPC 6 35515 99466 9 Distributed by C.D.M.A., Inc. 43157 W 9 Mile Rd, Novi, MI; d) CVS Health UPC 0 50428 37591 4 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895; e) Careone UPC 3 41520 31311 0 Distributed By: Foodhold U.S.A., LLC Landover, MD 20785; f) Market Basket UPC 0 49705 75280 7 Distributed By Demoulas Super Markets, Inc. 875 East Street, Tewksbury, MA 01876; g) Rexall UPC 0 72785 13848 3 Distributed By Old East Main Co. 100 Mission Ridge, Goodlettsville, TN 37072; h) HEB UPC 9 41220 25111 7 Distributed By: HEB San Antonio, TX 78204; i) Core Values UPC 0 79068 00707 8 Distributed by Liberty Procurement Co., Inc. Union, NJ 07083; j) Swan NDC 0869-0871-43 UPC 3 08694 70610 0 Distributed by Vi-Jon One Swan Drive, Smyrna, TN 37167; k) Cariba Care UPC 6 46702 05602 2 Distributed by: Cariba International P.O. Box 1208. Safety Harbor, Florida 34695; l) Kroger UPC 0 11110 79460 4 Distributed By The Kroger Co., Cincinnati, Ohio 45202; m) CVP Health UPC 7 61706 16314 6 Distributed By Salado Sales, Inc. Temple, TX 76503; n) Medline NDC 53329-981-06 UPC 0 80196 74870 2 Made in US with US and foreign components for Medline Industries, Inc., Northfield, IL 60093; o) Exchange Select UPC 6 14299 39968 6 Manufactured For Your Military Exchanges By: Vi-Jon 8515 Page Avenue, St. Louis, MO 63114; p) Premier Value UPC 8 40986 01021 7 Distributed by: Pharmacy Value Alliance LLC 407 East Lancaster Avenue Wayne, PA 19087; q) Publix UPC 0 41415 00973 8 Distributed By Publix Super Markets, Inc. 3300 Publix Corporate Parkway Lakeland, FL 33811; r) Being Well UPC 0 51933 13950 3 Distributed By: Moran Foods, LLC St. Ann, MO 63074; s) Medicare NPN 80016265 UPC 8 39748 00017 7 Manufactured by/Fabrique par: Vi-Jon Inc., Smyna, TN 37167; t) Swan NPN 80035214 UPC 0 72785 11239 1 Manufactured By: Vi-Jon, Inc. St. Louis, MO 63114; u) Equate NPN 80036214 UPC 6 28915 16613 3 Manufactured By: Vi-Jon, Inc. St. Louis, MO 63114; v) Iris UPC 61504-871-43 UPC 0 41512 12940 7 Distributed By: Amerifoods Trading Co. P.O. Box 512377, Los Angeles, CA 90051-0377; w) Equaline NDC 41163-871-43 UPC 0 41163 25134 2 Distributed by Supervalu Inc. Eden Prairie, MN 55344 USA; x) TopCare health UPC 0 36800 26711 4 Distributed By TopCo Associates LLC Elk Grove Village, IL 60007; y) Best Choice UPC 0 70038 20055 0 Distributed By: Valu Merchandisers, Co. 6000 Kansas Ave. Kansas City, KS 66106; z) Walgreens NDC 0363-0871-43 UPC 3 11917 20771 1 Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015; aa) Equate NDC 49035-871-43 UPC 6 81131 11871 2 Distributed By: Walmart, Inc., Bentonville, AR 72716

by Vi-Jon, LLC

Reason
Cross Contamination With Other Products: Product is cross contaminated with low levels of isopropyl alcohol.
Recall initiated
June 28, 2022
Reported by FDA
July 27, 2022
Distribution
Nationwide in the USA and Canada

View recall →

Drug Recall Terminated Historical recordClass I

Arti King Refozado con Ortiga y Omega 3 Tablets, 100-count bottles, Hecho en Mexico por: "PLANTAS MEDICINALES DE MEXICO", Melchor Ocampo No. 55 Local D, Delegacion Xochimilco, C.P. 16800 Mexico, UPC 7 501031 111138

by Latin Foods Market

Reason
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and dexamethasone.
Recall initiated
June 10, 2022
Reported by FDA
July 20, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Glutathione 200mg/ml, a) 10ml-vial, b) 30ml-vial, Refrigerate, Tailor Made Compounding

by TMC Acquisition LLC dba Tailor Made Compounding

Reason
Lack of Assurance of Sterility
Recall initiated
March 7, 2022
Reported by FDA
July 20, 2022
Distribution
Nationwide USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

Vitamin D3 50,000IU/mL, 10mL-vial, Room Temperature, Tailor Made Compounding

by TMC Acquisition LLC dba Tailor Made Compounding

Reason
Lack of Assurance of Sterility
Recall initiated
March 7, 2022
Reported by FDA
July 20, 2022
Distribution
Nationwide USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

Vitamin B-Complex Preservative Free, 3ml-vial, Refrigerate, Tailor Made Compounding

by TMC Acquisition LLC dba Tailor Made Compounding

Reason
Lack of Assurance of Sterility
Recall initiated
March 7, 2022
Reported by FDA
July 20, 2022
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.