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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 5,021–5,040 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

PDI Povidone-Iodine Swabstick (3's), 3 Swabsticks, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S41125 NDC 10819-3885-2, UPC (01)00310819000185

by Professional Disposables International, Inc

Reason
SubPotent: Out of Specification
Recall initiated
July 23, 2021
Reported by FDA
September 1, 2021
Distribution
Distributed Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass II

PDI Povidine Iodine Swabstick (1's), 1 swabstick, Professional Disposable International, Inc. Orangeburg, NY 10962 -1376 Reorder No S41350 NDC 10819-3885-1, UPC (01)00310819000178.

by Professional Disposables International, Inc

Reason
SubPotent: Out of Specification
Recall initiated
July 23, 2021
Reported by FDA
September 1, 2021
Distribution
Distributed Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass II

PDI Povidone-Iodine Prep Pad Large, 1 Prep Pad, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 USA Reorder No C12400 NDC 10819-3883-3, UPC (01)00310819000154

by Professional Disposables International, Inc

Reason
SubPotent: Out of Specification
Recall initiated
July 23, 2021
Reported by FDA
September 1, 2021
Distribution
Distributed Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass II

PDI Povidone-Iodine Prep Pad MEDIUM, 1 Prep Pad [2.0x2.5 in (5.1x6.4 cm)], Professional Disposables International Inc., Orangeburg, NY 10962-1376 Reorder No. B40600; UPC (01)00310819000147, NDC 10819-3883-1,

by Professional Disposables International, Inc

Reason
SubPotent: Out of Specification
Recall initiated
July 23, 2021
Reported by FDA
September 1, 2021
Distribution
Distributed Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass II

Micafungin for Injection, 100 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089. NDC 70594-037-01

by XELLIA PHARMACEUTICALS USA, LLC

Reason
Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include all required sections approved for this product. This includes aspects of Adverse Reactions, Drug Interactions and Use in Specific Populations.
Recall initiated
August 6, 2021
Reported by FDA
September 1, 2021
Distribution
Nationwide USA

View recall →

Drug Recall Terminated Historical recordClass II

Micafungin for Injection, 50 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089. NDC 70594-036-01

by XELLIA PHARMACEUTICALS USA, LLC

Reason
Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include all required sections approved for this product. This includes aspects of Adverse Reactions, Drug Interactions and Use in Specific Populations.
Recall initiated
August 6, 2021
Reported by FDA
September 1, 2021
Distribution
Nationwide USA

View recall →

Drug Recall Terminated Historical recordClass II

Pi yen chin Ophthalmic Redness Reliever Drops Made in China, Net Wt.: 10 ml (0.34 fl/oz) Exclusive U.S. Distributor: (Chinese writing)International Nature Nutraceuticals, Inc. New York, NY 10002 www.INNHERB.com. Konzon NDC 51367-008-10

by ANHUI WELCOME FOREIGN TRADE CO.,LTD.

Reason
Labeling: Not Elsewhere Classified; The packaging states these are ophthalmic drops. However, they are manufactured as nasal drops and sterility cannot be assured.
Recall initiated
August 12, 2021
Reported by FDA
September 1, 2021
Distribution
Distributed to: INTERNATIONAL NATURE NUTRACEUTICALS.INC. 39 BOWERY PMB 193,NEW YORK,NY 10002,U.S.A.

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Drug Recall Terminated Historical recordClass II

Carvedilol 25 mg, 180-count bottle, Rx only, Manufactured by Zydus Pharm, Pennington, NJ 08534, NDC 68382-0095-05, Repackaged by RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1826-01

by RemedyRePack Inc.

Reason
A 500 count bottle of Carvedilol 25 mg tablets contained two Paroxetine Tablets, 40 mg. Product was repackaged into 180 count bottles.
Recall initiated
August 17, 2021
Reported by FDA
September 1, 2021
Distribution
Product was distributed to two medical facilities in VA and FL.

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Drug Recall Terminated Historical recordClass II

Carvedilol Tablets, USP 25 mg, 500 Tablets bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 0853, NDC 68382-095-05

by Zydus Pharmaceuticals (USA) Inc

Reason
Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle
Recall initiated
August 13, 2021
Reported by FDA
August 25, 2021
Distribution
Nationwide in the US

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Drug Recall Terminated Historical recordClass II

Triamcinolone Acetonide Ointment USP, 0.1% 80 g cartons, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-014-80 ; packaged in tubes.

by Teligent Pharma, Inc.

Reason
Correct Labeled Product Mispack
Recall initiated
July 19, 2021
Reported by FDA
August 25, 2021
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Econazole Nitrate Cream 1%, 85 grams bulk shippers, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-022-85 ; packaged in tubes.

by Teligent Pharma, Inc.

Reason
Correct Labeled Product Mispack
Recall initiated
July 19, 2021
Reported by FDA
August 25, 2021
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Tizanidine HCl Tablets, USP 4 mg, 150-count bottles, Rx only, Mfd By: Dr. Reddy's Laboratories limited, Srikakulam District, 532 409 INDIA, NDC 55111-180-15.

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Tablet/Capsule Specification: Some tablets are shaved
Recall initiated
July 19, 2021
Reported by FDA
August 25, 2021
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Adenosine Injection, USP, 60mg/20 mL (3 mg/mL), 20 mL single-dose vial, Rx only, Mfd in the USA for: NorthStar Rx LLC Memphis, TN 38141, NDC 16714-180-01

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility
Recall initiated
July 29, 2021
Reported by FDA
August 25, 2021
Distribution
Product was distributed Nationwide, including Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Manufactured by: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-5145-91

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility
Recall initiated
July 29, 2021
Reported by FDA
August 25, 2021
Distribution
Product was distributed Nationwide, including Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Leucovorin Calcium for Injection, USP 100 mg/vial, 10 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-5140-01

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility
Recall initiated
July 29, 2021
Reported by FDA
August 25, 2021
Distribution
Product was distributed Nationwide, including Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Octreotide Acetate Injection 50 mcg/mL, 1 mL single-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3301-01

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility
Recall initiated
July 29, 2021
Reported by FDA
August 25, 2021
Distribution
Product was distributed Nationwide, including Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Octreotide Acetate Injection 100 mcg/mL, 1 mL single-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3311-01

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility
Recall initiated
July 29, 2021
Reported by FDA
August 25, 2021
Distribution
Product was distributed Nationwide, including Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Methylprednisolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0051-01), and b) 5mL Multi Dose Vials (NDC 0703-0063-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility
Recall initiated
July 29, 2021
Reported by FDA
August 25, 2021
Distribution
Product was distributed Nationwide, including Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Alprostadil Injection USP, 500 mg/mL, 1 mL single dose, vials, 5 mL single use vial per carton (NDC 0703-1501-02), Rx only, Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054, Vial NDC 0703-1501-01

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility
Recall initiated
July 29, 2021
Reported by FDA
August 25, 2021
Distribution
Product was distributed Nationwide, including Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Metoclopramide Injection USP, 10 mg/2mL (5 mg/mL) 2 mL single-use vial, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-4502-01

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility
Recall initiated
July 29, 2021
Reported by FDA
August 25, 2021
Distribution
Product was distributed Nationwide, including Puerto Rico.

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.