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Recall totals

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

37,061

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 recallhttps://www.fsis.usda.gov/recalls-alerts/el-eden-import-distributor-corp-recalls-ineligible-pork-cracklings-products-importedPublished September 9, 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 September 10, 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 I

Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-097-30.

by Dr. Reddy's Laboratories, Inc.

Reason: Sub-potent Drug; powder discoloration associated with decreased potency
Published: May 15, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922, NDC: 51991-748-90.

by Breckenridge Pharmaceutical, Inc

Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Published: May 15, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 20 mg, , 500-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922, NDC 51991-746-05.

by Breckenridge Pharmaceutical, Inc

Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Published: May 15, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles (NDC 51991-747-90), (b) 1000-count bottles (NDC 51991-747-10), Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.

by Breckenridge Pharmaceutical, Inc

Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Published: May 15, 2024
Distribution: Nationwide

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FDA Recall Completed Historical recordClass III

Valacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-4275-77

by Viatris Inc

Reason: Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.
Published: May 8, 2024
Distribution: Nationwide

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FDA Recall Completed Historical recordClass III

Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: Hikma Injectables USA Inc. 2 Esterbrook Lane, Cherry Hill, NJ 08003, Distributed by: Hikma Injectables USA Inc. 36 Stults Road, Dayton, NJ 08810, NDC 63037-100-05

by Hikma Injectables USA Inc

Reason: Labeling: Wrong Barcode
Published: May 8, 2024
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Syringe, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, NDC 61755-005-01

by Regeneron Pharmaceuticals Inc

Reason: Lack of Assurance of Sterility: Complaints of syringe breakage
Published: May 8, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass III

Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free, 1 mL Single-Use vials, Rx only, Imprimis NJOF, LLC 1705 Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC 71384-640-01

by Imprimis NJOF, LLC

Reason: Out of specification for assay
Published: May 8, 2024
Distribution: Nationwide

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FDA Recall Completed Historical recordClass II

Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bridgewater, NJ 08807, NDC # 69238-1605-2.

by Amneal Pharmaceuticals of New York, LLC

Reason: Failed Dissolution Specifications
Published: May 8, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution 1%, 0.5%, 0.075%, 8mL, Compounded By: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ 07852, NDC 71384-340-08

by Imprimis NJOF, LLC

Reason: Subpotent Drug
Published: May 8, 2024
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass II

OS Holding Inc

Product: Bottle is labeled as Johnny's Parmesan Garlic Seasoning, 5oz…
Reason: Undeclared Sesame. Johnny's Salad & Pasta Elegance product was mislabeled as Johnny's Parmesan Garlic Seasoning. The Johnny's Parmesan Garlic label did not declare sesame, but sesame seeds are visible through a clear plastic bottle.
Published: May 8, 2024
Distribution: Distributed in AK, ID, MT, ND, NV, OR,…

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FDA Recall Terminated Historical recordClass II

minolira (minocycline hydrochloride) extended-release tablets, 135mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Laboratories Limited, INDIA, Manufactured for: EPI Health, LLC, Charleston, SC 29403, NDC 71403-102-30.

by EPI Health, LLC

Reason: CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Published: May 1, 2024
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

minolira (minocycline hydrochloride) extended-release tablets, 105mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Laboratories Limited, INDIA, Manufactured for: EPI Health, LLC, Charleston, SC 29403, NDC 71403-101-30.

by EPI Health, LLC

Reason: CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Published: May 1, 2024
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Cloderm (clocortolone pivalate) Cream, 0.1%, Rx Only, For Topical Use Only, Net Wt 45g, Manufactured for: EPI Health, LLC, Charleston, SC 29403, NDC 71403-804-90

by EPI Health, LLC

Reason: CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Published: May 1, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ, 07430, Product of India, NDC 68462-562-01.

by Glenmark Pharmaceuticals Inc., USA

Reason: Failed Dissolution Specifications
Published: May 1, 2024
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton containing 30 vials ( 6 pouches of 5 - 3 mL vials), Rx only, Manufactured by: Cipla Ltd., Indore SEZ, Pithampur, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-173-53

by Cipla USA, Inc.

Reason: Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Published: May 1, 2024
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass I

ForeverMen Natural Energy Boost Capsules, packaged in a box containing a 10-count blister card.

by FA Online Inc

Reason: Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this unapproved drug.
Published: May 1, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass III

Abilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-011-13

by Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.

Reason: Cross Contamination with Other Products
Published: May 1, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass III

Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-009-13

by Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.

Reason: Cross Contamination with Other Products
Published: May 1, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass III

Abilify (aripiprazole), 10 mg tablets, packaged in a) 30 count bottles (NDC 59148-008-13) and b) 7 count blister packs (NDC 59148-008-95), RX only, Otsuka America Pharmaceutical, Inc.

by Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.

Reason: Cross Contamination with Other Products
Published: May 1, 2024
Distribution: Nationwide

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Data last updated: September 10, 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.