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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

CVS Health brand, Lubricant Gel Drops (Carboxymethylcellulose Sodium 1%) packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 76168-704-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 76168-704-30), Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895.

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 Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%), packaged in 0.5 FL OZ (15 mL) bottles, Cardinal Health Dublin, Ohio 43017, NDC 70000-0087-1

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

CVS brand Multi Action Relief Drops (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%) packaged in 0.5 FL OZ (15mL) bottles, Distributed by CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. NDC 76168-706-15

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

Leader brand Dry Eye Relief (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.33 FL OZ (10 mL) bottles, Distributed by Cardinal Health Dublin, Ohio 43017, NDC 70000-0088-1

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

CVS Health brand Lubricating Gel Drops (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%), packaged in 0.33 FL OZ (10 mL) bottles, Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. NDC 76168-712-10

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 Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1325-94

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

CVS Health brand Lubricant Eye Drops (Propylene glycol 0.6%), packaged in a) 0.33 FL OZ (10mL) bottles (Single Pack) (NDC 76168-714-10) and b) 0.33 FL OZ (10 mL) bottles (Twin pack) (NDC 76168-714-20), Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895.

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 (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 70000-0090-1) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 70000-0090-2), Distributed by: Cardinal Health Dublin, Ohio 43017

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 Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 76168-702-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 76168-702-30), Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895.

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 Terminated Historical recordClass II

Omeza Skin Protectant, Skin Protectant Gel 10*2mL Vials

by OMEZA LLC

Reason: CGMP Deviations
Recall initiated: January 19, 2024
Reported by FDA: February 14, 2024
Distribution: US Nationwide

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Drug Recall Terminated Historical recordClass II

Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS

by OMEZA LLC

Reason: CGMP Deviations
Recall initiated: January 19, 2024
Reported by FDA: February 14, 2024
Distribution: US Nationwide

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Drug Recall Terminated Historical recordClass I

Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle, Rx only, Mfd. for: Arbor Pharmaceuticals, LLC., Atlanta, Georgia, 30328, NDC 24338-856-03

by Azurity Pharmaceuticals, Inc.

Reason: Labeling: Label Mix-up
Recall initiated: January 4, 2024
Reported by FDA: February 7, 2024
Distribution: USA nationwide

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Drug Recall Ongoing Historical recordClass II

Hydrogen Peroxide Oral Rinse, Significantly Reduces Bacteria, Fresh Mint Flavor, Alcohol Free, a)16 fl. oz. (473 mL) bottle, NDC 59883-202-16, UPC 3 59883 00009 7); b) 64 fl. oz. (1.89 L) bottle, NDC 59883-202-64; c) 128 fl. oz. (1 gal) 3.78L bottle, NDC 59883-202-28, UPC 3 59883 00007 3), Manufactured by: Den-Mat Holdings, LLC, Lompoc, CA 93436.

by Den-Mat Holdings, LLC

Reason: CGMP Deviations: products may not conform to the labeled specifications.
Recall initiated: January 16, 2024
Reported by FDA: February 7, 2024
Distribution: Nationwide in the US

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Drug Recall Ongoing Historical recordClass II

OralProCare medicated lip treatment, Net Wt 9.9 g (0.35 oz) tube, Ethyl alcohol 6.0% Antibacterial, Manufactured by: Den-Mat Holdings, LLC, Lompoc, CA, 93436, USA, NDC 59883-500-01, UPC: 3 59883 00000 4.

by Den-Mat Holdings, LLC

Reason: CGMP Deviations: products may not conform to the labeled specifications.
Recall initiated: January 16, 2024
Reported by FDA: February 7, 2024
Distribution: Nationwide in the US

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Drug Recall Terminated Historical recordClass II

Rifampin Capsules USP, 150 mg, 30 Capsules (3 x 10) unit doses per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-575-21; NDC Unit Dose: 60687-575-11

by Amerisource Health Services LLC

Reason: Failed Impurities/Degradation Specification.
Recall initiated: January 11, 2024
Reported by FDA: February 7, 2024
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDC 68180-659-06

by Lupin Pharmaceuticals Inc.

Reason: Subpotent Drug and Failed Impurities/Degradation Specifications
Recall initiated: January 5, 2024
Reported by FDA: February 7, 2024
Distribution: Product was distributed to 32 Wholesale/distributor accounts who further distributed the product to 156 distribution sites.

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Drug Recall Terminated Historical recordClass II

Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDC 68180-658-06

by Lupin Pharmaceuticals Inc.

Reason: Subpotent Drug and Failed Impurities/Degradation Specifications
Recall initiated: January 5, 2024
Reported by FDA: February 7, 2024
Distribution: Product was distributed to 32 Wholesale/distributor accounts who further distributed the product to 156 distribution sites.

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Drug Recall Ongoing Historical recordClass I

VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-029-68.

by Denver Solutions, LLC DBA Leiters Health

Reason: Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Recall initiated: December 28, 2023
Reported by FDA: February 7, 2024
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass I

VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-028-68.

by Denver Solutions, LLC DBA Leiters Health

Reason: Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Recall initiated: December 28, 2023
Reported by FDA: February 7, 2024
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass I

PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Item F3352, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-150-82.

by Denver Solutions, LLC DBA Leiters Health

Reason: Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Recall initiated: December 28, 2023
Reported by FDA: February 7, 2024
Distribution: Nationwide within the United States

View recall →

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.