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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 2,181–2,200 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

Capsaicin Cream 0.025%, External Analgesic Cream, Penetrating Pain Relief, NET WT. 2.1 OZ. (60g) NDC 50268-195-60, Manufactured for: AvKARE, Pulaski, TN 38478

by AVKARE LLC

Reason
Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste
Recall initiated
August 11, 2023
Reported by FDA
September 13, 2023
Distribution
Affected product was distributed to nineteen (19) consignees within the united states.

View recall →

Drug Recall Terminated Historical recordClass II

Sodium Fluoride 1.1%, SODIUM FLUORIDE Prescription Dental Toothpaste, 5000 ppm Fluoride Plus Mild Cleaning System Spearmint NET WT. 1.8 OZ. (51g), Rx only, NDC 42291-741-51, Manufactured for: AvKARE Pulaski, TN 38478

by AVKARE LLC

Reason
Cases of Sodium Fluoride 1.1% Prescription Dental Toothpaste may contain cartons labeled as Capsaicin Cream 0.025% but contain correctly labeled tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste
Recall initiated
August 11, 2023
Reported by FDA
September 13, 2023
Distribution
Affected product was distributed to nineteen (19) consignees within the united states.

View recall →

Drug Recall Terminated Historical recordClass III

Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, Rx only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC# 67877-749-57

by Ascend Laboratories, LLC

Reason
Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.
Recall initiated
July 18, 2023
Reported by FDA
September 13, 2023
Distribution
The recall product was distributed nationwide.

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Drug Recall Terminated Historical recordClass III

Milrinone Lactate Injection, USP 20mg/20 mL (1mg/mL), packaged in 10 x 20 mL vials per carton, NDC 72485-502-01 (single vial), Rx only, Distributed by: Armas Pharmaceuticals, Inc. Freehold, NJ 07728(USA) Manufactured by: Caplin Steriles Limited, India, NDC 72485-502-10

by Caplin Steriles Limited

Reason
Failed Impurities/Degradation Specifications
Recall initiated
August 14, 2023
Reported by FDA
September 13, 2023
Distribution
Nationwide in Tennessee

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Drug Recall Completed Historical recordClass III

Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30 tablets, Rx only, Manufactured for: Esperion Therapeutics, Inc, Ann Arbor, MI 48108, NDC 72426-818-03

by Esperion

Reason
Failed dissolution specifications: below specification results at stability 12-month
Recall initiated
August 16, 2023
Reported by FDA
September 13, 2023
Distribution
Nationwide USA

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Drug Recall Ongoing Historical recordClass I

Vegetal Vigra, 200mg capsules, 8-count bottle, Manufacturer: Hand-shaking (Int'l) Corp. USA ADD: Hand-shaking Mansion, the 5th Ave., Stanford, USA. UPC 8 931028 556885

by APG SEVEN, INC

Reason
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil an ingredient found in a FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.
Recall initiated
August 3, 2023
Reported by FDA
September 6, 2023
Distribution
Nationwide in the USA

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Drug Recall Completed Historical recordClass III

Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, Rx only, Manufactured by: Patheon, Cincinnati, OH 45237, NDC 67386-211-65

by Lundbeck LLC

Reason
Cross contamination with other products
Recall initiated
August 17, 2023
Reported by FDA
September 6, 2023
Distribution
Nationwide within the U.S.

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Drug Recall Terminated Historical recordClass II

Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll Container with yellow pull ring, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA Product code L5B5193 NDC 0941-0411-07

by Baxter Healthcare Corporation

Reason
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Recall initiated
August 11, 2023
Reported by FDA
September 6, 2023
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, packaged in a) 2000 mL AMBU-FLEX II Container bag, Product Code L5B4825, NDC 0941-0409-06; b) 5000 mL AMBU-FLEX II Container bag, Product Code L5B4826, NDC 0941-0409-07; and c) 6000 mL AMBU-FLEX II Container bag, Product Code L5B9770, NDC 0941-0409-01, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.

by Baxter Healthcare Corporation

Reason
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Recall initiated
August 11, 2023
Reported by FDA
September 6, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass III

Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Rx only, Manufactured by: Contract Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, Manufactured for: Glasshouse Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, NDC# 71428-003-60

by Contract Pharmaceuticals Limited Canada

Reason
Defective Container: slow leakage under the cap
Recall initiated
August 23, 2023
Reported by FDA
September 6, 2023
Distribution
Nationwide in the USA.

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Drug Recall Terminated Historical recordClass II

dilTIAZem 125mg/125mL (1 mg/mL), added to dextrose 5%, IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6054-1

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Recall initiated
August 17, 2023
Reported by FDA
September 6, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

dilTIAZem 125mg/125mL (1 mg/mL), added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6055-1

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Recall initiated
August 17, 2023
Reported by FDA
September 6, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

vancomycin added to 0.9% Sodium Chloride, 1.25 g/250 mL (5 mg/mL), 250mL Excel Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6074-1

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Recall initiated
August 17, 2023
Reported by FDA
September 6, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

heparin added to 0.9% sodium chloride, 2500 units/500mL (5 units/mL), IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8100-1

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Recall initiated
August 17, 2023
Reported by FDA
September 6, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

oxyTOCIN, 40 units added to 0.9% sodium chloride 1000 mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8069-1

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Recall initiated
August 17, 2023
Reported by FDA
September 6, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL, IV Bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6044-1

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Recall initiated
August 17, 2023
Reported by FDA
September 6, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

oxyTOCIN 30 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6039-1

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Recall initiated
August 17, 2023
Reported by FDA
September 6, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

EPINEPHrine added to dextrose 5%, 4mg/250ml (16 mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7018-1.

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Recall initiated
August 17, 2023
Reported by FDA
September 6, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

EPINEPHrine added to 0.9% sodium chloride, 4mg/250mL (16 mcg/mL), IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-8093-1.

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Recall initiated
August 17, 2023
Reported by FDA
September 6, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

EPINEPHrine, 2 mg added to dextrose 5% 250mL, Concentration = 8 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6030-1.

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Recall initiated
August 17, 2023
Reported by FDA
September 6, 2023
Distribution
Nationwide in the USA

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.