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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 III

HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit dose carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-447-01; NDC Unit Dose: 68084-447-11

by Amerisource Health Services LLC

Reason: Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.
Recall initiated: February 1, 2024
Reported by FDA: February 14, 2024
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 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 60219-1502-01

by Amneal Pharmaceuticals of New York, LLC

Reason: Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Recall initiated: January 15, 2024
Reported by FDA: February 14, 2024
Distribution: USA nationwide.

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Drug Recall Terminated Historical recordClass II

Lansoprazole Delayed-Release Capsules USP, 15 mg, 14-count bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ. 08816. NDC 16571-742-41

by NATCO Pharma Limited

Reason: CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were missing on one bottle.
Recall initiated: February 1, 2024
Reported by FDA: February 14, 2024
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Medline Remedy Clinical TREAT Antifungal Cream, 2% Miconazole Nitrate, Paraben Free, 4 FL OZ (118 mL) tube, Manufactured for Medline Industries, LP Three Lakes Drive, Northfield, IL 60093. NDC: 53329-147-44

by MEDLINE INDUSTRIES, LP - Northfield

Reason: Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while the product does in fact contain parabens as part of the formulation/ ingredient list.
Recall initiated: January 10, 2024
Reported by FDA: February 14, 2024
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Febuxostat Tablets, 40 mg, 30 Tablets (3 x 10) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-538-21, NDC Unit dose 60687-538-11

by Amerisource Health Services LLC

Reason: CGMP Deviations
Recall initiated: January 25, 2024
Reported by FDA: February 14, 2024
Distribution: USA Nationwide

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Drug Recall Ongoing Historical recordClass III

Glimepiride Tablets, USP 1mg, 500-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA, NDC: 55111-320-05

by Dr. Reddy's Laboratories, Inc.

Reason: Misprint on tablet
Recall initiated: January 18, 2024
Reported by FDA: February 14, 2024
Distribution: Nationwide

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Drug Recall Ongoing Historical recordClass III

Glimepiride Tablets, USP 1mg, 100-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA, NDC: 55111-320-01

by Dr. Reddy's Laboratories, Inc.

Reason: Misprint on tablet
Recall initiated: January 18, 2024
Reported by FDA: February 14, 2024
Distribution: Nationwide

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Drug Recall Ongoing Historical recordClass I

Up&Up brand dry eye relief (Carboxymethylcellulose 0.5%) packaged in 0.5 FL OZ (15 mL) each bottles (Twin Pack), Distributed by: Target Corporation Minneapolis, MN 55403, NDC 76168-800-30

by Kilitch Healthcare India Limited

Reason: Non-Sterility
Recall initiated: November 13, 2023
Reported by FDA: February 14, 2024
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass I

Rugby brand Lubricating Tears Eye Drops (Dextran 70 0.1%, Hypromellose 2910 0.3%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1282-94

by Kilitch Healthcare India Limited

Reason: Non-Sterility
Recall initiated: November 13, 2023
Reported by FDA: February 14, 2024
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass I

Lubricant Eye Drops (Propylene glycol 0.6%), packaged in 0.33 FL OZ (10 mL) each bottle (Twin Pack), Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4811-3 Retail Labeler: Rite Aid

by Kilitch Healthcare India Limited

Reason: Non-Sterility
Recall initiated: November 13, 2023
Reported by FDA: February 14, 2024
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass I

Multi-action Relief Drops (Polyvinyl alcohol 0.5%, Providone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-2254-3

by Kilitch Healthcare India Limited

Reason: Non-Sterility
Recall initiated: November 13, 2023
Reported by FDA: February 14, 2024
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass I

Lubricant Gel Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%), packaged in 0.33 FL OZ (10 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4540-3

by Kilitch Healthcare India Limited

Reason: Non-Sterility
Recall initiated: November 13, 2023
Reported by FDA: February 14, 2024
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass I

Lubricant Gel Drops (Carboxymethylcellulose sodium 1.0%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4540-5

by Kilitch Healthcare India Limited

Reason: Non-Sterility
Recall initiated: November 13, 2023
Reported by FDA: February 14, 2024
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass I

CVS Health brand Mild Moderate Lubricating Eye Drops (Propylene glycol 400 0.25%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. NDC 76168-711-15

by Kilitch Healthcare India Limited

Reason: Non-Sterility
Recall initiated: November 13, 2023
Reported by FDA: February 14, 2024
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass I

LUBRICANT EYE DROPS (Carboxymethylcellulose Sodium 0.5%), packaged 0.5 FL OZ (15mL) bottles (Twin Pack), Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4811-5

by Kilitch Healthcare India Limited

Reason: Non-Sterility
Recall initiated: November 13, 2023
Reported by FDA: February 14, 2024
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass I

EQUATE brand Hydration PF Lubricant Eye Drops (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.34 FL OZ (10 mL) bottles, Distributed by: Walmart Inc., Bentonville, AR 72712, NDC 79903-168-01

by Kilitch Healthcare India Limited

Reason: Non-Sterility
Recall initiated: November 13, 2023
Reported by FDA: February 14, 2024
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass I

Velocity Pharma brand Lubricating Eye Drop (Propylene glycol Eye Drops 0.6%), packaged in 3 bottles of 0.33 FL OZ (10 mL) each, Velocity Pharma, NDC 76168-502-30

by Kilitch Healthcare India Limited

Reason: Non-Sterility
Recall initiated: November 13, 2023
Reported by FDA: February 14, 2024
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass I

Leader brand Lubricant Eye Drops (Propylene glycol Eye Drops 0.6%), packaged in 0.33 FL OZ (10 mL) bottles, Cardinal Health Dublin, Ohio 43017, NDC 70000-0587-1

by Kilitch Healthcare India Limited

Reason: Non-Sterility
Recall initiated: November 13, 2023
Reported by FDA: February 14, 2024
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass I

Target brand High Performance Lubricant Eye Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%) a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 11673-522-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 11673-522-30), Distributed by: Target Corporation Minneapolis, MN 55403

by Kilitch Healthcare India Limited

Reason: Non-Sterility
Recall initiated: November 13, 2023
Reported by FDA: February 14, 2024
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass I

Leader brand Dry Eye Relief (Carboxymethylcellulose Sodium 1%), packaged in 0.5 FL OZ (15 mL) bottles, Cardinal Health Dublin, Ohio 43017, NDC 70000-0089-1

by Kilitch Healthcare India Limited

Reason: Non-Sterility
Recall initiated: November 13, 2023
Reported by FDA: February 14, 2024
Distribution: Nationwide within the United States

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Data last updated: November 1, 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.