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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 821–840 of 17,898 drug recalls

Drug Recall Ongoing Historical recordClass II

Iodo Blanco Iodides, First Aid Antiseptic, Mercury Free, Iodine 2%, First Aid Antiseptic, Contains 1 fl. oz (30 ml) per bottle, Distributed by: Essential Products, www.essentialproductsusa.com, NDC: 70242-109-01

by World Perfumes Inc.

Reason
Defective Container: broken or leaking bottles.
Recall initiated
February 13, 2025
Reported by FDA
September 17, 2025
Distribution
FL

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Drug Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands. NDC: 82009-030-10

by Breckenridge Pharmaceutical, Inc.

Reason
CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
Recall initiated
August 8, 2025
Reported by FDA
September 17, 2025
Distribution
AZ, IN, NJ

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Drug Recall Ongoing Historical recordClass II

4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only, 10 mL Single Dose Vial, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC, Lenoir, NC 28645 USA, NDC 51754-5012-1 (vial); 51754-5012-4 (carton)

by Exela Pharma Sciences LLC

Reason
Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Recall initiated
July 30, 2025
Reported by FDA
September 17, 2025
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass I

0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7800-09

by B BRAUN MEDICAL INC

Reason
Presence of Particulate Matter.
Recall initiated
August 18, 2025
Reported by FDA
September 10, 2025
Distribution
U.S.A. Nationwide

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Drug Recall Ongoing Historical recordClass I

Lactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07

by B BRAUN MEDICAL INC

Reason
Presence of Particulate Matter
Recall initiated
August 18, 2025
Reported by FDA
September 10, 2025
Distribution
U.S.A. Nationwide

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Drug Recall Ongoing Historical recordClass II

chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1062-1.

by Amneal Pharmaceuticals, LLC

Reason
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Recall initiated
August 18, 2025
Reported by FDA
September 10, 2025
Distribution
Distributed Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1060-1.

by Amneal Pharmaceuticals, LLC

Reason
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Recall initiated
August 18, 2025
Reported by FDA
September 10, 2025
Distribution
Distributed Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1058-1.

by Amneal Pharmaceuticals, LLC

Reason
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Recall initiated
August 18, 2025
Reported by FDA
September 10, 2025
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1056-1.

by Amneal Pharmaceuticals, LLC

Reason
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Recall initiated
August 18, 2025
Reported by FDA
September 10, 2025
Distribution
Distributed Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Packaged as a) 100-count bottle, NDC 65162-272-10; b) 500-count bottle, NDC 65162-272-50; Manufactured by: Amneal Pharmaceuticals, Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807.

by Amneal Pharmaceuticals, LLC

Reason
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Recall initiated
August 18, 2025
Reported by FDA
September 10, 2025
Distribution
Distributed Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

KIMMTRAK (tebentafusp-tebn) Injection, 100 mcg/0.5 mL, For intravenous Infusion After Dilution, Single-Does vial. Mfd by: Immunocore Limited, 92 Park Drive, Abingdon, Oxfordshire, OX14 4RY, United Kingdom, For: Immunocore Commercial LLC, 181 Washington St, Conshohocken, PA, 19428, Product of Denmark NDC 80446-0401-01 Lot #: 3D009AA09, 3D009AA10, 3D009AA25, Exp Date: 31 MAR 2026 NDC 80446-0401-99 (Non-Commercial FG) Lot #: 3D009AA02, Exp Date 31 MAR 2026

by IMMUNOCORE, LLC

Reason
Subpotent Drug
Recall initiated
June 10, 2025
Reported by FDA
September 10, 2025
Distribution
US Nationwide

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Drug Recall Ongoing Historical recordClass I

PeriGiene, Health Care Antiseptic, (Chloroxylenol 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-198-08

by DermaRite Industries, LLC

Reason
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Recall initiated
July 17, 2025
Reported by FDA
September 10, 2025
Distribution
Nationwide within the USA

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Drug Recall Ongoing Historical recordClass I

KleenFoam, Antimicrobial Foam Soap with Aloe Vera, (Chloroxylenol 0.5%) 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-093-34

by DermaRite Industries, LLC

Reason
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Recall initiated
July 17, 2025
Reported by FDA
September 10, 2025
Distribution
Nationwide within the USA

View recall →

Drug Recall Ongoing Historical recordClass I

DermaSarra, External Analgesic, (Camphor 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-189-08

by DermaRite Industries, LLC

Reason
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Recall initiated
July 17, 2025
Reported by FDA
September 10, 2025
Distribution
Nationwide within the USA

View recall →

Drug Recall Ongoing Historical recordClass I

DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E (Chloroxylenol 0.2%), packaged in a) 800 ml (27 fl. oz.) bag-n-box (NDC 61924-092-27) and b) 1000ml (34 fl. oz.) bag-n-box (NDC 61924-092-34) , DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.

by DermaRite Industries, LLC

Reason
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Recall initiated
July 17, 2025
Reported by FDA
September 10, 2025
Distribution
Nationwide within the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Semaglutide, 2.5 mg/mL injection, 4 mL, Boothwyn Pharmacy

by Boothwyn Pharmacy LLC

Reason
Subpotent Drug
Recall initiated
July 9, 2025
Reported by FDA
September 10, 2025
Distribution
U.S. Nationwide

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Drug Recall Ongoing Historical recordClass II

Semaglutide, 2.5 mg/mL injection, 0.8 mL, Boothwyn Pharmacy

by Boothwyn Pharmacy LLC

Reason
Subpotent Drug
Recall initiated
July 9, 2025
Reported by FDA
September 10, 2025
Distribution
U.S. Nationwide

View recall →

Drug Recall Ongoing Historical recordClass III

Fluorescein 2% Ophth, 3 ML, Boothwyn Pharmacy, 800-476-7496

by Boothwyn Pharmacy LLC

Reason
Subpotent Drug
Recall initiated
July 9, 2025
Reported by FDA
September 10, 2025
Distribution
U.S. Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Semaglutide, 2.5 mg/mL injection, 2 mL., Boothwyn Pharmacy

by Boothwyn Pharmacy LLC

Reason
Subpotent Drug
Recall initiated
July 9, 2025
Reported by FDA
September 10, 2025
Distribution
U.S. Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

RITE AID PHARMACY, first aid alcohol prep pads, DISTRIBUTED BY: RITE AID. 200 NEWBERRY COMMONS, ETTERS, PA 17319, NDC 11822-5156-2.

by MEDLINE INDUSTRIES, LP - Northfield

Reason
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Recall initiated
July 7, 2025
Reported by FDA
September 3, 2025
Distribution
Nationwide

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.