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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: PA ×
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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 II

Dexonto 0.4% (dexamethasone sodium phosphate) solution 20 mg/5 mL (4 mg/mL), Rx Only, 12 - 5 mL Single Dose Units per box, Preservative Free, For Iontophoresis Use Only, Non-Sterile Product, Not for Injection, NUBRATORI RX, 381 Van Ness Ave# 1507, CA 90501, NDC 71300-6564-1 (box), 71300-6564-3 (vial).

by Nubratori, Inc

Reason: Labeling: Incorrect or Missing Lot and/or Expiration date: Individual vials of Dexonto 0.4%, are labeled correctly with the BUD of 12/25/2024, however, the outer box on some of the Dexonto 0.4% are labeled incorrectly with a BUD of 12/25/2025.
Published: May 7, 2025
Distribution: PA and CA.

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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

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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

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FDA Recall United States Terminated Historical recordClass II

Giant Eagle, Inc.

Product: Multigrain Sourdough Freshly Backed, and Half Multigrain Sou…
Reason: Firm is recalling product due to the potential of foreign material (glass)
Published: May 7, 2025
Distribution: The recalled product was distributed to…

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FDA Recall United States Terminated Historical recordClass II

Gordon Desserts DBA Mochidoki

Product: Sundae Shoppe, Cookies and Cream Mochi Ice Cream, 6 count, 7…
Reason: Undeclared Wheat and Soy
Published: May 7, 2025
Distribution: The recalled product was distributed to…

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FDA Recall United States Terminated Historical recordClass II

Upper Crust Bakery LP

Product: Whole Grain Multigrain , 20 oz, Paper carton (corrugated),…
Reason: Glass fragment found on top of bread.
Published: May 7, 2025
Distribution: The recalled product was distributed to…

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FDA Recall United States Terminated Historical recordClass II

Upper Crust Bakery LP

Product: Multigrain Sourdough , 18 oz, Paper carton (corrugated), CP…
Reason: Glass fragment found on top of bread.
Published: May 7, 2025
Distribution: The recalled product was distributed to…

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FDA Recall United States Terminated Historical recordClass II

Upper Crust Bakery LP

Product: Ancient Grains Hoagie Roll, 4 oz, Paper carton (corrugated)…
Reason: Glass fragment found on top of bread.
Published: May 7, 2025
Distribution: The recalled product was distributed to…

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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 Ongoing Historical recordClass II

Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC; 70518-3772-00

by RemedyRePack Inc.

Reason: CGMP Deviations
Published: April 30, 2025
Distribution: PA

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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

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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

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FDA Recall Ongoing Historical recordClass II

dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg (base) per mL), 5mL Single Dose syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112, NDC: 71449-131-11.

by Denver Solutions, LLC DBA Leiters Health

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

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FDA Recall Ongoing Historical recordClass II

Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC 71449-104-11

by Denver Solutions, LLC DBA Leiters Health

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

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FDA Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-count bottles (NDC 51991-747-10), Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L. Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922

by Breckenridge Pharmaceutical, Inc

Reason: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Published: April 30, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L., Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922, NDC# 51991-748-10

by Breckenridge Pharmaceutical, Inc

Reason: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Published: April 30, 2025
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Bimatoprost powder, Bulk Ingredient, a) 5g (NDC 38779-3066-03), b) 1g (NDC 38779-3066-06), c) 1g (NDC 38779-3066-09) drums, Medisca, Plattsburgh, NY

by Medisca Inc.

Reason: CGMP Deviations
Published: April 30, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-004-11

by Denver Solutions, LLC DBA Leiters Health

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