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Recall totals

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

37,210

Total recall recordsAll FDA and USDA recalls in Public Health Trace

9,841

Class I recallsReasonable probability of serious health consequences

24,366

Class II recallsTemporary or medically reversible health consequences

2,892

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 2,073 recalls

Newest recallhttp://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/frutas-y-hortalizas-del-sur-sa-expands-recalls-include-additional-lots-great-value-frozen-organicPublished October 2, 2026

Most affected stateHawaii 200 recalls mention this state

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

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Source: FDA and USDA public dataLast updated October 3, 2026 ET

Summary (Year to date)

1,714 recalls have been announced year to date.
Sep 2026 was 3% higher than the previous complete period (Aug 2026: 182).
The highest complete period was Jun 2026 (297).
Oct 2026 is incomplete and not included in the figures above.

Complete data
Incomplete

Recalls by class

Recalls by class
Class	Recalls
Class II	24,366
Class I	9,841
Class III	2,892
Not Yet Classified	2

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Recalls by class
Class	Recalls
Class II	24,366
Class I	9,841
Class III	2,892
Not Yet Classified	2

FDA Recall Terminated Historical recordClass II

B-12 PFS, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200

by Main Street Family Pharmacy, LLC

Reason: The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Published: December 11, 2013
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

B-12 1ml prefilled syringe, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200

by Main Street Family Pharmacy, LLC

Reason: The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Published: December 11, 2013
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Aminophylline 250mg 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200

by Main Street Family Pharmacy, LLC

Reason: The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Published: December 11, 2013
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

AMIC-12 w/out lido10ml , Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200

by Main Street Family Pharmacy, LLC

Reason: The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Published: December 11, 2013
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Alprostadil 100mcg/ml 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200

by Main Street Family Pharmacy, LLC

Reason: The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Published: December 11, 2013
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Alphahydroxyprogesterone, 250mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200

by Main Street Family Pharmacy, LLC

Reason: The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Published: December 11, 2013
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

17-P 1ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200

by Main Street Family Pharmacy, LLC

Reason: The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Published: December 11, 2013
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Morphine Sulfate Injection, USP, (25mg/mL), 250 mg, 10mL Fill, Single dosage Flip top Vial, (C-II), (NDC 0409-1135-02), Rx Only, Manfactured for Hospira, Inc., Lake Forest, IL 60045 USA.

by Hospira, Inc.

Reason: Lack of Assurance of Sterility: Confirmed customer report of leakage of vial contents due to the breaking of the vial neck.
Published: December 11, 2013
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Loratadine, USP 10 mg, Antihistamine, packaged in blister packs. All manufactured by Novartis Consumer Health, Inc, Lincoln, NE / There are 7 different labels under which this product is packaged but the active ingredient is the same. 1) DOLLAR GENERAL LABEL: DG Health Allergy Relief, Loratadine, USP 10 mg, Antihistamine, packaged in 60 tablet blister packs (UPC code: 300436122) and 30 tablet blister packs (UPC code: 300676122304). Distributed by Dolgencorp, LLC, Goodlettsville, TN. 2) FAMILY DOLLAR LABEL: Family Wellness Allergy Relief, Loratadine, USP 10 mg, Antihistamine, packaged in 30 tablet blister packs (UPC code: 032251004292). Distributed by Family Dollar Services, Inc, Matthews, NC. 3) FAMILY DOLLAR LABEL Family Dollar Allergy Relief, Loratadine, USP 10 mg, Antihistamine, packaged in 30 tablet blister packs (UPC code: 400910131502). Manufactured by Novartis Consumer Health, Inc, Lincoln, NE and Distributed by Family Dollar Services, Inc, Charlotte, NC. 4) TARGET LABEL: Allergy Relief Medication, loratadine, 10 mg/antihistamine, packaged in 10 tablet (UPC 300670675103), 15 tablet (UPC 300670668150), 30 tablet (UPC 300670675301), 40 tablet (UPC 300670675400), and 60 tablet (UPC 300670675004) blister packs. It is also packaged in 120 tablet (UPC 300670675127) and 180 tablet (UPC 300676255736) bottles. Dist. by Target Corporation, Minneapolis, MN. 5) PRIVATE LABEL: Loratadine 10mg, Antihistamine, packaged in 10 tablet (UPC 300670674106) and 30 tablet (UPC 300670674304) blister packs. Manufactured and Distributed by: Novartis Consumer Health, Inc., Lincoln, NE. 6) WALMART LABEL, Equate, Allergy Relief, Loratadine Tablets, 10 mg, Antihistamine, packaged in 10 tablet (UPC 681131739276) and 30 tablet (UPC 681131739283) blister packs. Distributed by: Wal-Mart Stores, Inc., Bentonville, AR. 7) CVS LABEL: CVS Pharmacy, Allergy Relief, Loratadine 10mg/Antihistamine, packaged in 5 tablet (UPC 050428068595), 10 tablet (UPC 050428046784), 20 tablet (UPC 050428065747) (UPC 050428579350), and 30 tablet (UPC 050428046791) blister packs. Also packaged in 120 tablet (UPC 050428065822) and 365 tablet (UPC 050428160282) plastic bottles. Manufactured by: Novartis Consumer Health, Inc., Lincoln, NE, for: CVS Pharmacy, Inc., Woonsocket, RI.

by Novartis Consumer Health

Reason: Failed Tablet/Capsule Specifications: The products are being recalled due to chipped and broken tablets.
Published: December 4, 2013
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass I

J.R. Jack Rabbit All Natural Herbal Supplement, One tablet can last 24-72 hours, 4-count tablets per blister pack, Order at: www.jackrabbitfourpack.com, Jack Rabbit Inc., 4355 Dow Road, Melbourne, FL 32934

by Jack Rabbit, Inc

Reason: Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that J.R. Jack Rabbit Male Enhancement product was found to contain two undeclared active pharmaceutical ingredients: sildenafil and tadalafil.
Published: December 4, 2013
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Cetacaine Liquid Topical Anesthetic, Rx Only, a) 14 g bottle (NDC 10223-0202-2); Kit w/14 g (NDC 10223-0202-3); 30 g bottle (NDC 10223-0202-4) Manufactured by Cetylite Industries, Inc., 9051 River Road Pennsauken, NJ 08110 -

by Cetylite Industries, Inc.

Reason: Subpotent Drug: Cetacaine Topical Anesthetic Liquid is being recalled because one of the three active ingredients, tetracaine, is below the specification limit at the 21 month stability test point.
Published: December 4, 2013
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Alprazolam Orally Disintegrating Tablets, USP 2 mg, 100 count bottles, Rx Only, MFG. BY ACTAVIS ELIZABETH LLC., Elizabeth, NJ, NDC 0228-4025-11

by Actavis Elizabeth LLC

Reason: Failed Tablet/Capsule Specifications; partial tablet erosion resulting in tablet weights below specification in some tablets
Published: December 4, 2013
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Acyclovir Tablets USP 800 mg ,(NDC 60505-5307-1), Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for Apotex Corp.,Weston, Florida 33326.

by Apotex Inc.

Reason: Presence of Particulate Matter: Product from lot KF2199, may contain tablets with pieces of nitrile rubber glove embedded within the tablets.
Published: December 4, 2013
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

PACLITAXEL INJECTION, USP (semisynthetic); 300 mg/50 mL; (6 mg/mL); Multiple Dose Vial;(NDC 63323-763-50); Rx Only; Manufactured for APP Pharmaceuticals, LLC; Schaumburg, IL 60173; Made in India

by Fresenius Kabi USA, LLC

Reason: Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinical Studies" and "Specific Adverse Events" sections.
Published: December 4, 2013
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass I

Affirm XL Nutritional Supplement, 1 and 10 count blister packs and single pill packs, Manufactured by Dongseo Biopharm Corp., Yongin City, Kyonggi do, Korea, distributed by: Affirm XL, LLC, Ladera Ranch, CA

by Affirm XL, Inc.

Reason: Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain sulfoaildenafil, an analogue of sildenafil which is an ingredient in an FDA-approved drug for the treatment of male erectile dysfunction, making this an unapproved new drug.
Published: November 27, 2013
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Aldactone (spironolactone) tablets, USP, 100 mg, 100-count bottles, Rx only, Distributed by G.D. Searle, Division of Pfizer Inc, NY, NY 10017, NDC 0025-1031-31

by Pfizer Us Pharmaceutical Group

Reason: Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a manufacturing site change. There is currently no approved application supporting the alternate manufacturing site.
Published: November 27, 2013
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL Single-dose Vial, Rx Only, Sterile, Hospira Inc., Lake Forest IL 60045, USA, NDC 0409-4755-03

by Hospira Inc.

Reason: Presence of Particular Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.
Published: November 27, 2013
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Metoclopramide Injection, USP 10 mg (5mg/mL), 2 mL Single-dose Vial, Rx Only, Sterile, Hospira Inc., Lake Forest, IL, 60045, USA, NDC 0409-3414-01

by Hospira Inc.

Reason: Presence of Particulate Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.
Published: November 27, 2013
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Spironolactone tablets, USP 50 mg, Rx only, 100 count bottle, Distributed By: Greenstone LLC, Peapack, NJ 07977, NDC: 59762-5012-1

by Greenstone Llc

Reason: Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a manufacturing site change. There is currently no approved application supporting the alternate manufacturing site.
Published: November 27, 2013
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Spironolactone tablets, USP 25 mg, Rx only, 500 count bottle, Distributed By: Greenstone LLC, Peapack, NJ 07977, NDC: 59762-5011-2.

by Greenstone Llc

Reason: Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a manufacturing site change. There is currently no approved application supporting the alternate manufacturing site.
Published: November 27, 2013
Distribution: Nationwide

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Data last updated: October 3, 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.