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Recall totals

All FDA and USDA recalls in Public Health Trace, June 2012 to September 2026.

37,063

Total recall recordsAll FDA and USDA recalls in Public Health Trace

9,786

Class I recallsReasonable probability of serious health consequences

24,313

Class II recallsTemporary or medically reversible health consequences

2,876

Class III recallsNot likely to cause adverse health consequences

Quick insights

A snapshot of the most notable patterns across all recorded FDA and USDA recalls.

Most recalled product100 vegetarian Fenugreek Capsules 90 count, 600mg, packaged in 150cc Amber Glass Packer with White Polypropylene Cap. 53 recalls

Most common hazardLack of assurance of sterility 2,072 recalls

Newest recallhttp://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/evergreen-fresh-sprouts-llc-recalls-broccoli-sprouts-because-possible-health-riskPublished September 10, 2026

Most affected stateHawaii 200 recalls mention this state

State: MP ×
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Recalls announced by month (Year to date)

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Source: FDA and USDA public dataLast updated September 11, 2026 ET

Summary (Year to date)

1,527 recalls have been announced year to date.
Aug 2026 was 24% lower than the previous complete period (Jul 2026: 240).
The highest complete period was Jun 2026 (297).
Sep 2026 is incomplete and not included in the figures above.

Complete data
Incomplete

Recalls by class

Recalls by class
Class	Recalls
Class II	24,313
Class I	9,786
Class III	2,876
Not Yet Classified	2

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Recalls by class
Class	Recalls
Class II	24,313
Class I	9,786
Class III	2,876
Not Yet Classified	2

FDA 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
Published: February 14, 2024
Distribution: Nationwide

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FDA 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
Published: February 14, 2024
Distribution: Nationwide

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FDA 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
Published: February 14, 2024
Distribution: Nationwide

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FDA 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
Published: February 14, 2024
Distribution: Nationwide

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FDA 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
Published: February 14, 2024
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

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

by OMEZA LLC

Reason: CGMP Deviations
Published: February 14, 2024
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS

by OMEZA LLC

Reason: CGMP Deviations
Published: February 14, 2024
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass III

NOW Foods

Product: Protocol for Life Balance, Phosphatidyl Serine 300mg softgel…
Reason: Amount of Phosphatidyl Serine in product is less than stated on the label
Published: February 14, 2024
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass II

County Fair Foods, Inc.

Product: Popcorn Pre-Pop in 8oz Polypropylene bag packaged 20 bags to…
Reason: Undeclared Yellow #5
Published: February 14, 2024
Distribution: Nationwide

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FDA 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
Published: February 7, 2024
Distribution: Nationwide

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FDA 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.
Published: February 7, 2024
Distribution: Nationwide

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FDA 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.
Published: February 7, 2024
Distribution: Nationwide

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FDA 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.
Published: February 7, 2024
Distribution: Nationwide

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FDA 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.
Published: February 7, 2024
Distribution: Nationwide

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FDA 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.
Published: February 7, 2024
Distribution: Nationwide

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FDA 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.
Published: February 7, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass I

PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-148-94.

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.
Published: February 7, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass I

FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3342, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-82.

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.
Published: February 7, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass I

FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-41.

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.
Published: February 7, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Budesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 0591-2510-30

by Teva Pharmaceuticals USA, Inc

Reason: Failed Dissolution Specifications
Published: February 7, 2024
Distribution: Nationwide

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Data last updated: September 11, 2026 ET

Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions. Read the full medical disclaimer.