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Research historical outbreak investigations and the full recall archive, with charts, trends, and advanced filters. Looking for what's happening right now instead? See current Health Alerts.

Recall totals

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

37,060
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/freshpoint-issues-recall-due-improperly-declared-allergen-egg-chicken-salad-wedge-sandwichesPublished September 8, 2026
Most affected stateHawaii 200 recalls mention this state

Download matching recalls as CSV

CSV exports include up to 5,000 matching rows (applying your current filters), not the full dataset if it's larger.

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Recalls announced by month (Year to date)

A chart of recalls grouped by month.

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Source: FDA and USDA public dataLast updated

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

A bar chart of the total number of recalls in this dataset by recall class.

Recalls by class
ClassRecalls
Class II24,313
Class I9,786
Class III2,876
Not Yet Classified2
Download CSV
Recalls by class
ClassRecalls
Class II24,313
Class I9,786
Class III2,876
Not Yet Classified2

Showing 1,341–1,360 of 17,805 recalls

FDA Recall Ongoing Historical recordClass II

Lubricant Eye Drops Solution, Polyethylene Glycol 400 0.4% Eye Lubricant, Propylene Glycol 0.3% Eye Lubricant, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-126-15.

by BRS Analytical Services, LLC

Reason
cGMP deviations and lack of assurance of sterility.
Published
May 14, 2025
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Carboxymethlycellulose Sodium 0.5% Eye Lubricant, Lubricating Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-068-15.

by BRS Analytical Services, LLC

Reason
cGMP deviations and lack of assurance of sterility.
Published
May 14, 2025
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethlycellulose Sodium 1% Eye Lubricant, Lubricant Eye Gel, Soothing Gel, Sterile, 0.5 FL OZ (15mL) per bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-066-15.

by BRS Analytical Services, LLC

Reason
cGMP deviations and lack of assurance of sterility.
Published
May 14, 2025
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Artificial Tears Ophthalmic Solution, Dextran 70.01%/Glycerin 0.2%/Hypromellose 0.3% (Eye Lubricants) Lubricant Eye Drops, STERILE, 0.5 FL OZ (15 mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-043-15.

by BRS Analytical Services, LLC

Reason
cGMP deviations and lack of assurance of sterility.
Published
May 14, 2025
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-01.

by FDC Limited

Reason
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Published
May 14, 2025
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass I

Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Mehsana, India, , Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807 NDC 70121-1734-1 (bag); NDC 70121-1734-3 (box)

by Amneal Pharmaceuticals, LLC

Reason
Presence of Particulate Matter
Published
May 14, 2025
Distribution
Nationwide

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FDA Recall United States Terminated Historical recordClass I

Optimal Carnivore, LLC

Product
Bone & Joint Restore. 180 capsules in a plastic bottle. Shel…
Reason
Potential for contamination with salmonella.
Published
May 14, 2025
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC carton: 0517-0735-10 / NDC Vial: 0517-0735-01]

by American Regent, Inc.

Reason
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Published
May 7, 2025
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, Mfd for: Civica, Inc., Lehi, UT 84043,Mfd by: American Regent, Inc., New Albany, OH 43064. NDC Carton: 72572-470-10/ NDC Vial: 72572-470-01.

by American Regent, Inc.

Reason
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Published
May 7, 2025
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 90 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-452-15

by ACCORD HEALTHCARE, INC.

Reason
Subpotent
Published
May 7, 2025
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-450-17

by ACCORD HEALTHCARE, INC.

Reason
Subpotent
Published
May 7, 2025
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-448-17.

by ACCORD HEALTHCARE, INC.

Reason
Subpotent
Published
May 7, 2025
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-447-17

by ACCORD HEALTHCARE, INC.

Reason
Subpotent
Published
May 7, 2025
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Clindamycin Hydrochloride Capsules, USP, 300mg, 30-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, NDC 68788-8685-03.

by Preferred Pharmaceuticals, Inc.

Reason
cGMP Deviations
Published
May 7, 2025
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL), 250 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.S. LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-430-01

by Eugia US LLC

Reason
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Published
May 7, 2025
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL), 100 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.S. LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-429-01

by Eugia US LLC

Reason
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Published
May 7, 2025
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake Rd., Fayetteville, AR 72701, NDC 73013-1040-01.

by OurPharma LLC

Reason
Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
Published
April 30, 2025
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States, Manufactured By: Lupin Limited, Nagpur, 441 108 INDIA, NDC 68180-492-01

by Lupin Pharmaceuticals Inc.

Reason
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study.
Published
April 30, 2025
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112.NDC: 71449-068-11

by Denver Solutions, LLC DBA Leiters Health

Reason
Lack of Assurance of Sterility: Leaking/damaged syringes.
Published
April 30, 2025
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-001-11,

by Denver Solutions, LLC DBA Leiters Health

Reason
Lack of Assurance of Sterility: Leaking/damaged syringes.
Published
April 30, 2025
Distribution
Nationwide

View recall →

Data last updated:

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.