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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 1,461–1,480 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

Thiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg per 100 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-079-56

by Fresenius Kabi Compounding, LLC

Reason
cGMP violations
Recall initiated
September 25, 2024
Reported by FDA
October 30, 2024
Distribution
Product was distributed to 125 direct accounts nationwide.

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Drug Recall Terminated Historical recordClass II

EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-060-58

by Fresenius Kabi Compounding, LLC

Reason
cGMP violations
Recall initiated
September 25, 2024
Reported by FDA
October 30, 2024
Distribution
Product was distributed to 125 direct accounts nationwide.

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Drug Recall Terminated Historical recordClass II

Oxytocin 0.9% Sodium Chloride Injection USP, 30 units per 500 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-028-59

by Fresenius Kabi Compounding, LLC

Reason
cGMP violations
Recall initiated
September 25, 2024
Reported by FDA
October 30, 2024
Distribution
Product was distributed to 125 direct accounts nationwide.

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Drug Recall Terminated Historical recordClass II

NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-027-58

by Fresenius Kabi Compounding, LLC

Reason
cGMP violations
Recall initiated
September 25, 2024
Reported by FDA
October 30, 2024
Distribution
Product was distributed to 125 direct accounts nationwide.

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Drug Recall Terminated Historical recordClass II

NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-025-58

by Fresenius Kabi Compounding, LLC

Reason
cGMP violations
Recall initiated
September 25, 2024
Reported by FDA
October 30, 2024
Distribution
Product was distributed to 125 direct accounts nationwide.

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Drug Recall Terminated Historical recordClass II

Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-014-58

by Fresenius Kabi Compounding, LLC

Reason
cGMP violations
Recall initiated
September 25, 2024
Reported by FDA
October 30, 2024
Distribution
Product was distributed to 125 direct accounts nationwide.

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Drug Recall Terminated Historical recordClass II

Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-029-58

by Fresenius Kabi Compounding, LLC

Reason
cGMP violations
Recall initiated
September 25, 2024
Reported by FDA
October 30, 2024
Distribution
Product was distributed to 125 direct accounts nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-010-58

by Fresenius Kabi Compounding, LLC

Reason
cGMP violations
Recall initiated
September 25, 2024
Reported by FDA
October 30, 2024
Distribution
Product was distributed to 125 direct accounts nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-024-58

by Fresenius Kabi Compounding, LLC

Reason
cGMP violations
Recall initiated
September 25, 2024
Reported by FDA
October 30, 2024
Distribution
Product was distributed to 125 direct accounts nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-002-58

by Fresenius Kabi Compounding, LLC

Reason
CGMP violations
Recall initiated
September 25, 2024
Reported by FDA
October 30, 2024
Distribution
Product was distributed to 125 direct accounts nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

First Aid Antiseptic Ointment, Povidone Iodine USP 10%, Inactive Ingredients: mineral oil, petrolatum. NET Wt. 1 OZ (28.4 g) per tube, Distributed by: Rugby Laboratories, Indianapolis, IN 46268. Made in China. NDC: 0536-1271-80

by Zhejiang Jingwei Pharmaceutical Co., Ltd.

Reason
Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The inactive ingredients in the actual product are polyethylene glycol 400 , polyethylene glycol 4000.
Recall initiated
September 11, 2024
Reported by FDA
October 23, 2024
Distribution
Distributed to one wholesaler in OH for Nationwide distribution.

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Drug Recall Terminated Historical recordClass I

Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, NDC # 69452-252-87.

by Bionpharma Inc.

Reason
Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
Recall initiated
September 17, 2024
Reported by FDA
October 23, 2024
Distribution
Nationwide in the U.S.A.

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Drug Recall Ongoing Historical recordClass II

Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02.

by VIONA PHARMACEUTICALS INC

Reason
Crystallization
Recall initiated
September 24, 2024
Reported by FDA
October 23, 2024
Distribution
NY

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Drug Recall Terminated Historical recordClass II

Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multiple Dose Vial, Rx Only, Manufactured for: Accord Healthcare Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad 382 213, India. Mfg. Lic. No.: G/28/1336, NDC 16729-288-38

by ACCORD HEALTHCARE, INC.

Reason
Failed Impurities/Degradation Specifications.
Recall initiated
October 1, 2024
Reported by FDA
October 23, 2024
Distribution
Nationwide within the United States and PR

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Drug Recall Completed Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Distributed by: BPI, NDC 51991-746-05.

by Breckenridge Pharmaceutical, Inc

Reason
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Recall initiated
October 10, 2024
Reported by FDA
October 23, 2024
Distribution
Product was distributed nationwide within the United States

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Drug Recall Ongoing Historical recordClass I

Vail-Bon Jie Yang Wan capsules, 30-count bottle, Vall Boon Medical Factory Sdn. Bhd., No 1, Lorong Mengkudu, Taman Mengkudu, 14100 Juru, Malaysia.

by 123Herbals

Reason
Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone and chlorpheniramine.
Recall initiated
September 18, 2024
Reported by FDA
October 16, 2024
Distribution
Distributed via Amazon and 123Herbals.com website

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Drug Recall Ongoing Historical recordClass II

Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection, Single-dose vial, Sterile, Manufacturer Advanced Accelerator Applications, 57 E. Willow Street, NJ 07041, Millburn USA. NDC 69488-0010-61

by Advanced Accelerator Applications USA, Inc.

Reason
CGMP deviations
Recall initiated
September 23, 2024
Reported by FDA
October 9, 2024
Distribution
FL, MA, NJ, NY, PA, and VA

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Drug Recall Ongoing Historical recordClass II

Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray, 665 mcg/25 mcg per spray, 240 Metered Sprays/bottle, 29 g net fill weight, Distr. by Hikma Specialty USA Inc., Columbus, OH 43328, hikma, Glenmark Specialty SA. NDC 59467-700-27.

by Glenmark Pharmaceuticals Inc., USA

Reason
Defective Delivery System: The dip tube is clogged causing the spray not to work.
Recall initiated
September 24, 2024
Reported by FDA
October 9, 2024
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass I

Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manufactured for: Gilead Sciences, Inc., Foster City, CA 94404, NDC 61958-2901-2

by Gilead Sciences, Inc.

Reason
Presence of Particulate Matter: Presence of glass particle.
Recall initiated
September 19, 2024
Reported by FDA
October 9, 2024
Distribution
Nationwide in the U.S.A.

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Drug Recall Ongoing Historical recordClass I

Gold Hard Steel Plus Liquid, 2 FL OZ bottles, UPC 787188873199

by Supercore Products Group Inc.

Reason
Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Recall initiated
July 12, 2024
Reported by FDA
October 9, 2024
Distribution
Nationwide US (2014), Israel (2), Canada (12), Republic of Kosovo (1), Pakistan (1), Australia (3), Morocco (1), United Kingdom (1)

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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.