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Recall totals

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

36,950

Total recall recordsAll FDA and USDA recalls in Public Health Trace

9,732

Class I recallsReasonable probability of serious health consequences

24,263

Class II recallsTemporary or medically reversible health consequences

2,873

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 2,071 recalls

Newest recallhttp://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/made-fresh-salads-inc-recalls-ready-eat-deli-style-salads-and-cream-cheese-because-possible-healthPublished September 6, 2026

Most affected stateHawaii 200 recalls mention this state

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

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Source: FDA and USDA public dataLast updated September 7, 2026 ET

Summary (Year to date)

1,458 recalls have been announced year to date.
Aug 2026 was 53% 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	24,263
Class I	9,732
Class III	2,873
Not Yet Classified	1

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Recalls by class
Class	Recalls
Class II	24,263
Class I	9,732
Class III	2,873
Not Yet Classified	1

FDA Recall Ongoing Historical recordClass III

Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56

by Dr. Reddy's Laboratories, Inc.

Reason: Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Published: December 17, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., (a subsidary of Cipla Ltd) Hauppauge, NY 11786, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33422, Carton NDC 76282-478-90; Bottle NDC 76282-478-13.

by Cipla USA, Inc.

Reason: Failed stability specifications: Out of specification for hardness test
Published: December 17, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., Hauppauge, NY 11786, Manufactured for : Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-936-98.

by Cipla USA, Inc.

Reason: Failed stability specifications: Out of specification for hardness test
Published: December 17, 2025
Distribution: Nationwide

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FDA Recall United States Ongoing Historical recordClass I

ByHeart, INC.

Product: 1. ByHeart Whole Nutrition Infant Formula cans 24 OZ 680 gra…
Reason: Contaminated with Clostridium botulinum
Published: December 17, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748-10.

by Breckenridge Pharmaceutical, Inc.

Reason: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Published: December 10, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Manufactured for : Quallient Pharmaceuticals Health, LLC, Grand Cayman, Cayman Islands, NDC 82009-032-10.

by Breckenridge Pharmaceutical, Inc.

Reason: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Published: December 10, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Wecare Calasoothe, Net wt. 4 oz (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, NDC 67777-234-04.

by Blossom Pharmaceuticals

Reason: cGMP deviations
Published: December 10, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Globe Zinc Oxide Ointment USP Zinc Oxide 20% Skin Protectant, Net Wt. 2 oz (56.7 g), Distributed by: Trifecta Pharmaceuticals USA 101 NE, Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301, NDC 69396-086-02.

by Blossom Pharmaceuticals

Reason: cGMP deviations
Published: December 10, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Globe Clotrimazole Cream USP, 1 % Antifungal Cream, Net Wt., 5 oz. (142 g, Distributed by: Trifecta Pharmaceuticals USA, 101 NE Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301, USA, NDC 69396-087-55.

by Blossom Pharmaceuticals

Reason: cGMP deviations
Published: December 10, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Globe Clotrimazole Cream, USP, 1 %, Net Wt. 1 oz (28.4g), Distributed by: Trifecta Pharmaceuticals USA, 101 NE Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301 USA, Made in India, NDC 69396-087-01.

by Blossom Pharmaceuticals

Reason: cGMP deviations
Published: December 10, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 %, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA, Made in India, NDC 75834-170-02.

by Blossom Pharmaceuticals

Reason: cGMP deviations
Published: December 10, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Nivagen, Zinc Oxide Ointment, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA Made in India, NDC 75834-170-01.

by Blossom Pharmaceuticals

Reason: cGMP deviations
Published: December 10, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Dynashield, 4 oz cream (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10852, USA, Made in India, NDC 67777-407-03.

by Blossom Pharmaceuticals

Reason: cGMP deviations
Published: December 10, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Nivagen Pharmaceuticals, Zinc Oxide Ointment USP, Zinc Oxide 20% Skin Protectant, Net Wt. 15 oz (425g), Made in India, Manufactured for: Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA, NDC 75834-170-15.

by Blossom Pharmaceuticals

Reason: cGMP deviations
Published: December 10, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

WeCare, Zinc Oxide Ointment, Net Wt. 15 oz/425 g, Manuactured for: Dynarex Corporation, 11 Dynarex Drive, Middletown, NY 10941, Made in India, NDC 67777-223-05.

by Blossom Pharmaceuticals

Reason: cGMP deviations
Published: December 10, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Dynagel, Moisturizing Wound Hydrogel, Net Wt. 3oz (84.7 g), Manufactured for: Dynarex Corporation, 16 Glenshaw Street, Orangeburg, NY 10962, UPC 61784128016.

by Blossom Pharmaceuticals

Reason: cGMP deviations
Published: December 10, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Wecare Enema, 4.5 Fl Oz/133mL, Manufactured for: Dynarex Corporation, 11 Dynarex Corporation, MIddletown, NY 10941 USA, Made in India, NDC 67777-402-01.

by Blossom Pharmaceuticals

Reason: cGMP deviations
Published: December 10, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Dynashield Skin Protectant, Net Wt. 16 oz (453.6 g), Manufactured for: Dyrnarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, USA, Made in India, NDC 67777-407-04.

by Blossom Pharmaceuticals

Reason: cGMP deviations
Published: December 10, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Lanashield Skin Barrier, 4 oz. (113 g), Manfuactured for: Dynarex Corporation, 10 Gleshaw Street, Orangeburg, NY 10962 USA, Made in India, UPC 616784126319.

by Blossom Pharmaceuticals

Reason: cGMP deviations
Published: December 10, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass III

Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30; (b) 100-count bottle, NDC-68462-878-01; (c) 500-count bottles, NDC-68462-878-05; Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, Inda. Manufactured for: Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430.

by Glenmark Pharmaceuticals Inc., USA

Reason: Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
Published: December 10, 2025
Distribution: Nationwide

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Data last updated: September 7, 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.