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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: PR ×
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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 Completed Historical recordClass II

Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-255-01

by Zydus Pharmaceuticals (USA) Inc

Reason: Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Published: November 15, 2023
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Deferasirox Tablets for Oral Suspension, 500mg, 30-count bottle, Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-496-30

by Glenmark Pharmaceuticals Inc., USA

Reason: Failed Dissolution Specifications
Published: November 15, 2023
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass III

Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg, 100 Tablets per bottle, Rx only, Distributed by: Zyla Life Sciences US Inc., Wayne, PA 19087. NDC: 69344-213-11

by Zyla Life Sciences US Inc.

Reason: Sub-potent Drug: Lower potency than labeled.
Published: November 15, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, Manufactured for: VistaPharm, Inc., Largo, FL 33771, USA, NDC#66689-307-08.

by VistaPharm LLC

Reason: Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.
Published: November 15, 2023
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur Dist - Dhar, Madhya Pradesh - 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-319-60.

by Glenmark Pharmaceuticals Inc., USA

Reason: Failed Dissolution Specifications: Out of specification for dissolution.
Published: November 15, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Clinical TREAT Antifungal Powder, Vanilla Scent, 3 OZ (85 g) tube, Active Ingredient: Miconazole Nitrate 2.0% w/w Antifungal, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, NDC: 53329-169-79

by MEDLINE INDUSTRIES, LP - Northfield

Reason: CGMP deviations: the product was shipped from the Manufacturer to a Medline warehouse and released to stock while it was still under investigation for low assay results on the active ingredient miconazole nitrate.
Published: November 15, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10

by Amneal Pharmaceuticals of New York, LLC

Reason: Failed Dissolution Specifications
Published: November 15, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada LGT 1C, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC 51672-3007-1

by Taro Pharmaceuticals Inc.

Reason: Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
Published: November 15, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1mL Single Dose Vial, (supplied in packages of 5 vials) Distributed by Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC: 42023-179-05

by Par Sterile Products LLC

Reason: Crystallization; identified as Buprenorphine free base
Published: November 15, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Reddy's Laboratories., Princeton, NJ 08540, Made in India, NDC# 55111-725-10.

by Dr. Reddy's Laboratories, Inc.

Reason: Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg.
Published: November 15, 2023
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass I

WANABANA USA LLC

Product: WANABANA APPLE CINNAMON FRUIT PUREE, Net Weight: 2.50 oz (71…
Reason: North Carolina Department of Health and Human Services (NCDHHS) sampled product and found it to contain high levels of lead.
Published: November 15, 2023
Distribution: Virginia, Kentucky, California, Puerto R…

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FDA Recall United States Terminated Historical recordClass III

The Sausage Maker, Inc.

Product: The Sausage Maker Instacure #1
Reason: Contains Sodium Nitrite recalled for potential metal contamination
Published: November 15, 2023
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass I

WANABANA USA LLC

Product: Schnucks APPLE SAUCE FRUIT POUCH, CINNAMON Net Weight: 3.2 o…
Reason: North Carolina Department of Health and Human Services (NCDHHS) sampled product and found it to contain high levels of lead.
Published: November 15, 2023
Distribution: Virginia, Kentucky, California, Puerto R…

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FDA Recall United States Terminated Historical recordClass I

WANABANA USA LLC

Product: Weis CINNAMON APPLE SAUCE, Net Weight: 3.2 oz (90g) Pouches,…
Reason: North Carolina Department of Health and Human Services (NCDHHS) sampled product and found it to contain high levels of lead.
Published: November 15, 2023
Distribution: Virginia, Kentucky, California, Puerto R…

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FDA Recall Terminated Historical recordClass III

Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, 100-count Bottle, RX only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-879-01

by Glenmark Pharmaceuticals Inc., USA

Reason: Failed Impurities/Degradation Specifications
Published: November 8, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Liothyronine Sodium Tablets, USP, 25 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191,(U.T. of D & NH), India. NDC 62756-590-88

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason: Failed Impurities/Degradation Specifications.
Published: November 8, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Liothyronine Sodium Tablets, USP, 5 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191,(U.T. of D & NH), India. NDC 62756-589-88

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason: Failed Impurities/Degradation Specifications.
Published: November 8, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Strong Iodine Solution U.S.P. (Lugol's Solution) (Iodine 5%), 14 mL Glass Dropper bottle in box, RX only, Safecor Health, LLC, Woburn, MA 01801. NDC# 48433-230-15

by Safecor Health, LLC

Reason: CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.
Published: November 8, 2023
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled applicator, packaged in 1 prefilled applicator per carton, Rx Only, Manufactured By Padagis, Yeruham, Israel; Distributed By: Padagis, Allegan, MI 49010. NDC: 45802-396-01

by Padagis US LLC

Reason: Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.
Published: November 8, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine, packaged in 118 mL (4 Fl oz) bottles, Rx only, Manufactured for: Edenbridge Pharmaceuticals, LLC Parsippany, NJ 07054, NDC 42799-217-01

by Edenbridge Pharmaceuticals, LLC

Reason: Subpotent Drug
Published: November 8, 2023
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.