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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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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

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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

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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

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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

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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

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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

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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

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Drug Recall Ongoing Historical recordClass II

Good Neighbor Pharmacy, Alcohol Prep Pads, Distributed By AmeriSource Bergen, 1 West First Avenue, Conshohocken, PA 19428, Made in China: 100 eaches per box, 30 boxes per case, (3,000 eaches per case), NDC 46122-043-78.

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

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Drug Recall Ongoing Historical recordClass II

H-E-B, inControl, Sterile* Alcohol Pads, CONT. 100 PADS, Packaged in China with components from Taiwan, Elaborado Con Orgullo Y Cuidado PARA H-E-B, San Antonio, TX 78204, NDC 37808-809-09.

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

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Drug Recall Ongoing Historical recordClass II

ReliOn, Sterile Alcohol Swabs, Skin Cleanser, 200 Swabs, Distributed by, Walmart, Inc., Bentonville, AR 72716 Walmart: 200 eaches per box, 24 boxes per case (4,800 eaches per case), NDC 49035-814-60.

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

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Drug Recall Ongoing Historical recordClass II

CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093, USA, Made in India, www.curad.com, 1-800-633-5463, NDC 53329-827-30

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

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Drug Recall Ongoing Historical recordClass II

Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large, www.medline.com, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, 1-800-MEDLINE, NDC 53329-811-30.

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

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Drug Recall Terminated Historical recordClass II

Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 0527-4664-37

by Lannett Company Inc.

Reason: Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
Recall initiated: August 11, 2025
Reported by FDA: September 3, 2025
Distribution: Nationwide within the USA

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Drug Recall Ongoing Historical recordClass II

Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]

by Amerisource Health Services LLC

Reason: CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Recall initiated: July 29, 2025
Reported by FDA: September 3, 2025
Distribution: Nationwide

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Drug Recall Ongoing Historical recordClass II

Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, packaged in 0.3 mL prefilled syringes further packaged in bags of 5 prefilled syringes, Rx Only, Dist. by: Sandoz Inc., Princeton, NJ 08540, Outer package - NDC 55154-3543-5, Inner label - NDC 0781-3238-01

by Cardinal Health Inc.

Reason: Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
Recall initiated: August 5, 2025
Reported by FDA: September 3, 2025
Distribution: KS

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Drug Recall Ongoing Historical recordClass II

Acetaminophen Injection 1000 mg/100 mL (10 mg/mL), packaged in 100 mL Viaflo container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in Ireland, NDC 36000-306-60.

by Baxter Healthcare Corporation

Reason: Discoloration
Recall initiated: August 20, 2025
Reported by FDA: September 3, 2025
Distribution: U.S.A. Nationwide

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Drug Recall Ongoing Historical recordClass II

Tavaborole Topical Solution 5%, 10 mL per glass bottle, Rx Only, For Topical Use Only, Manufactured by: Zydus Lifesciences Ltd., Changodar Ahmedabad, India. Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016. NDC: 72578-102-04

by VIONA PHARMACEUTICALS INC

Reason: Discoloration
Recall initiated: August 12, 2025
Reported by FDA: August 27, 2025
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by Major Pharmaceuticals, Indianapolis, IN, 46268, USA, NDC 0904-7307-61

by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Reason: CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Recall initiated: August 20, 2025
Reported by FDA: August 27, 2025
Distribution: Product was distributed nationwide within the United States.

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Data last updated: October 30, 2026 ET

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.