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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 121–140 of 17,898 drug recalls

Drug Recall Ongoing 2026 recordClass II

BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as: a) 25 x 26 mL applicators/case, NDC 54365-400-38, calatog number 930815NS: b) 50 x 26 mL appliactors/case, bulk catalog number 930815NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co.

by CareFusion 213, LLC

Reason
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Recall initiated
June 11, 2026
Reported by FDA
July 8, 2026
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass II

BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x 3 mL applicators/case, NDC 54365-400-33, calatog 930415NS: b) 250 x 3mL applicators/case, bulk catalog number 930415NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co.

by CareFusion 213, LLC

Reason
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Recall initiated
June 11, 2026
Reported by FDA
July 8, 2026
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass II

ChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 500 x 1.5 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-30, Catalog number 930599NSB

by CareFusion 213, LLC

Reason
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Recall initiated
June 11, 2026
Reported by FDA
July 8, 2026
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass II

BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG), and 70% v/v isopropyl alcohol (IPA), Packaged as a) 100 x 3ml applicators/case, NDC 54365-400-32, catalog 930400NS; b) 250 x 3ml applicators/case, NDC 54365-400-32, bulk Catalog 930500NSB, Sterile Solution, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co.

by CareFusion 213, LLC

Reason
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Recall initiated
June 11, 2026
Reported by FDA
July 8, 2026
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass II

BD PurPrep, (Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w), 50 x 26 mL Applicator/case, STERILE SOLUTION, CAREFUSION 213, LLC, EL PASO, TX 79912, subsidiary of Beckton, Dickson and Co, Catalog Number 960120NSB; NDC 54365-014-42.

by CareFusion 213, LLC

Reason
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Recall initiated
June 11, 2026
Reported by FDA
July 8, 2026
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass II

BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), packaged as a) 100 x 10.5 mL applicators/case, NDC 54365-400-35, Catalog Number: 930715NS; b) 100 x 10.5 mL applicators/case, Catalog Number bulk 930715NSB, NDC 54365-400-35; STERILE SOLUTION, CAREFUSION 213, LLC, EL PASO, TX 79912, subsidiary of Beckton, Dickson and Co.

by CareFusion 213, LLC

Reason
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Recall initiated
June 11, 2026
Reported by FDA
July 8, 2026
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass II

Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 51672-4206-6

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
Recall initiated
June 17, 2026
Reported by FDA
July 1, 2026
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass II

Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care, LLC, 346 Pike Road, Suite 6, West Palm Beach, FL 33411, NDC 57511-0611-1.

by Elevate Oral Care

Reason
sub potency
Recall initiated
June 4, 2026
Reported by FDA
July 1, 2026
Distribution
Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

Lacosamide Tablets, USP, C V, 100mg, Rx only, 60-count bottle, By: Annora Pharma Pvt., Ltd, Sangareddy -502313, Telangana, India, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, NDC 31722-813-60.

by Annora Pharma Private Limited

Reason
Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg.
Recall initiated
June 4, 2026
Reported by FDA
July 1, 2026
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass I

BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-30.

by CareFusion 213, LLC

Reason
Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Recall initiated
May 28, 2026
Reported by FDA
July 1, 2026
Distribution
Nationwide inthe USA, as well as other foreign distribution.

View recall →

Drug Recall Ongoing 2026 recordClass I

BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 1 mL Applicator, 60 Applicators per inner Carton, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-31.

by CareFusion 213, LLC

Reason
Non-Sterility: Due to presence of Aspergillus penicillioides.
Recall initiated
May 28, 2026
Reported by FDA
July 1, 2026
Distribution
Nationwide inthe USA, as well as other foreign distribution.

View recall →

Drug Recall Ongoing 2026 recordClass II

BD ChloraPrep FREPP Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-30.

by CareFusion 213, LLC

Reason
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Recall initiated
May 28, 2026
Reported by FDA
July 1, 2026
Distribution
Nationwide inthe USA, as well as other foreign distribution.

View recall →

Drug Recall Ongoing 2026 recordClass II

BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1 mL Applicator, 60 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-31.

by CareFusion 213, LLC

Reason
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Recall initiated
May 28, 2026
Reported by FDA
July 1, 2026
Distribution
Nationwide inthe USA, as well as other foreign distribution.

View recall →

Drug Recall Ongoing 2026 recordClass II

PReye Vitamin See Antioxidant Preservative Free Eye Drops, Distributed by: PReye, LLC, Golden, CO

by PReye LLC

Reason
Lack of Assurance of Sterility
Recall initiated
May 18, 2026
Reported by FDA
July 1, 2026
Distribution
CO

View recall →

Drug Recall Ongoing 2026 recordClass III

hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC: 70954-912-10

by ANI Pharmaceuticals, Inc.

Reason
Presence of foreign substance
Recall initiated
June 2, 2026
Reported by FDA
July 1, 2026
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass II

Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Rx# 24-1269856-0-1Compound Volume 1295 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Boston, 55 6th Rd Woburn, Massachusetts 01801-1767.

by Central Admixture Pharmacy Services, Inc.

Reason
Incorrect product formulation: bag did not contain copper and famotidine per label.
Recall initiated
June 2, 2026
Reported by FDA
July 1, 2026
Distribution
MA

View recall →

Drug Recall Ongoing 2026 recordClass II

DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx.

by Direct Rx

Reason
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Recall initiated
June 22, 2026
Reported by FDA
July 1, 2026
Distribution
U.S. Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

Sensipar (cinacalcet) Tablets, 90mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks, CA 91320-1799, Made in Japan. NDC 55513-075-30

by Amgen, Inc.

Reason
CGMP Deviations
Recall initiated
June 4, 2026
Reported by FDA
July 1, 2026
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing 2026 recordClass II

Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy. NDC 55513-810-60

by Amgen, Inc.

Reason
Presence of Foreign Substance.
Recall initiated
June 4, 2026
Reported by FDA
July 1, 2026
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing 2026 recordClass II

Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-074-30

by Amgen, Inc.

Reason
CGMP Deviations
Recall initiated
June 4, 2026
Reported by FDA
July 1, 2026
Distribution
Nationwide within the United States

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.