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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 Terminated Historical recordClass II

Jardiance (empagliflozin tablets), 25 mg, 30 tablets (3 blister cards with 10 tablets each), Rx only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877. NDC: 0597-0153-37

by CARDINAL HEALTHCARE

Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recall initiated: January 26, 2022
Reported by FDA: January 3, 2024
Distribution: Nationwide USA

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Drug Recall Terminated Historical recordClass II

HydrALAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816. NDC: 23155-002-01

by CARDINAL HEALTHCARE

Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recall initiated: January 26, 2022
Reported by FDA: January 3, 2024
Distribution: Nationwide USA

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Drug Recall Terminated Historical recordClass II

FOLIC ACID TABLETS, USP, 1MG, 100 Tablets per bottle, Rx Only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004. NDC: 69315-127-10

by CARDINAL HEALTHCARE

Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recall initiated: January 26, 2022
Reported by FDA: January 3, 2024
Distribution: Nationwide USA

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Drug Recall Terminated Historical recordClass II

Fluticasone Propionate Nasal Spray USP, 50MCG per spray, 16 g net fill weight, 120 Metered Sprays, For Intranasal Use Only, Rx Only, Manufactured for: Apotext Corp., Weston, FL 33326. NDC: 60505-0829-1

by CARDINAL HEALTHCARE

Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recall initiated: January 26, 2022
Reported by FDA: January 3, 2024
Distribution: Nationwide USA

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Drug Recall Terminated Historical recordClass II

FIRST LANSOPRAZOLE PT 3MG/ML, 300ML, Rx Only, Distributed By: CutisPharma, Inc., Woburn, MA 01801. NDC: 65628-080-10

by CARDINAL HEALTHCARE

Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recall initiated: January 26, 2022
Reported by FDA: January 3, 2024
Distribution: Nationwide USA

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Drug Recall Terminated Historical recordClass II

ESTRADIOL TABLETS USP, 0.5MG 100 Tablets, Tx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. NDC: 0555-0899-02

by CARDINAL HEALTHCARE

Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recall initiated: January 26, 2022
Reported by FDA: January 3, 2024
Distribution: Nationwide USA

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Drug Recall Terminated Historical recordClass II

Enoxaparin Sodium Injection, USP, 150MG/ML Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Ten 1 mL Syringes per box, Rx Only, Sandoz Inc, Princeton, NJ 08540. NDC: 0781-3299-69

by CARDINAL HEALTHCARE

Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recall initiated: January 26, 2022
Reported by FDA: January 3, 2024
Distribution: Nationwide USA

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Drug Recall Terminated Historical recordClass II

Doxycycline Capsules, USP 100 mg, 50 Capsules, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 Unite States; Manufactured by: Lupin Limited, Nagpur - 441 108, INDIA. NDC 68180-652-08

by CARDINAL HEALTHCARE

Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recall initiated: January 26, 2022
Reported by FDA: January 3, 2024
Distribution: Nationwide USA

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Drug Recall Terminated Historical recordClass II

Donepezil HCl Tablets, 5 mg, 90 Tablets, Rx only, Distributed by: Solco Healthcare U.S. LLC, Hurracao, Puerto Rico 00791. NDC: 43547-275-09

by CARDINAL HEALTHCARE

Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recall initiated: January 26, 2022
Reported by FDA: January 3, 2024
Distribution: Nationwide USA

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Drug Recall Terminated Historical recordClass II

Donepezil HCl Tablets, 10 mg, 90 Tablets, Rx only, Distributed by: Solco Healthcare U.S. LLC, Hurracao, Puerto Rico 00791. NDC: 43547-276-09

by CARDINAL HEALTHCARE

Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recall initiated: January 26, 2022
Reported by FDA: January 3, 2024
Distribution: Nationwide USA

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Drug Recall Terminated Historical recordClass II

Dicyclomine Hydrochloride Tablets, USP 20 mg, 100 Tablets, Rx only, Manufactured For: Teva Pharmaceuticals USA, Parsippany, NJ 07054. NDC: 0591-0795-01

by CARDINAL HEALTHCARE

Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recall initiated: January 26, 2022
Reported by FDA: January 3, 2024
Distribution: Nationwide USA

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Drug Recall Terminated Historical recordClass II

Colgate Total SF Toothpaste, Net Wt 4.8 oz (136 g), Stannous Fluoride 0.454%, Clean Mint, Dist. by: COLGATE-PALMOLIVE CO., New York, NY 10022 USA

by CARDINAL HEALTHCARE

Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recall initiated: January 26, 2022
Reported by FDA: January 3, 2024
Distribution: Nationwide USA

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Drug Recall Terminated Historical recordClass II

CITALOPRAM Tablets, USP, 20MG, 100 Tablets, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 0378-6232-01

by CARDINAL HEALTHCARE

Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recall initiated: January 26, 2022
Reported by FDA: January 3, 2024
Distribution: Nationwide USA

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Drug Recall Terminated Historical recordClass II

CHLORTHALIDONE Tablets, USP, 25MG, 1000 Tablets, Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854 USA; Manufactured For: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA. NDC: 43598-719-10

by CARDINAL HEALTHCARE

Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recall initiated: January 26, 2022
Reported by FDA: January 3, 2024
Distribution: Nationwide USA

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Drug Recall Terminated Historical recordClass II

Bumetanide Tablets, USP, 2 mg, 100 Tablets per bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213 India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807

by CARDINAL HEALTHCARE

Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recall initiated: January 26, 2022
Reported by FDA: January 3, 2024
Distribution: Nationwide USA

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Drug Recall Terminated Historical recordClass II

Low Dose ASPIRIN, 81 mg, 120 Enteric Coated Tablets, Distributed by: Rugby Lavoratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1234-41

by CARDINAL HEALTHCARE

Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recall initiated: January 26, 2022
Reported by FDA: January 3, 2024
Distribution: Nationwide USA

View recall →

Drug Recall Terminated Historical recordClass II

Asmanex Twisthaler (mometasone furoate inhalation powder, 220 mcg per actuation), 120 Metered Doses, Rx only, Manufactured for: Organon LLC, a subsidiary of Organon & Co., Jersey City, NJ 07302; Manufactured by: MSD International GmbH (Singapore Branch) Singapore 638030, Singapore. NDC: 78206-114-01

by CARDINAL HEALTHCARE

Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recall initiated: January 26, 2022
Reported by FDA: January 3, 2024
Distribution: Nationwide USA

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Drug Recall Terminated Historical recordClass II

ARMOUR THYROID (thyroid tablets, USP), 2 GRAIN (120 mg), 100 Tablets, Rx Only, Distributed by: Allergan US, INc., Madison, NJ 07940. NDC: 0456-0461-01

by CARDINAL HEALTHCARE

Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recall initiated: January 26, 2022
Reported by FDA: January 3, 2024
Distribution: Nationwide USA

View recall →

Drug Recall Terminated Historical recordClass II

Aripiprazole Tablets, USP, 5 mg, 30 Tablets per bottle, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 65162-897-03

by CARDINAL HEALTHCARE

Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recall initiated: January 26, 2022
Reported by FDA: January 3, 2024
Distribution: Nationwide USA

View recall →

Drug Recall Terminated Historical recordClass II

AMOXICILLIN Tablets, USP, 875MG, 20 Tablets, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540. NDC: 0781-5060-20

by CARDINAL HEALTHCARE

Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recall initiated: January 26, 2022
Reported by FDA: January 3, 2024
Distribution: Nationwide USA

View recall →

Data last updated: September 9, 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.