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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: AS ×
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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 II

Amphotericin B Liposome for Injection, 50mg vials, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Medicare Limited, Baska Ujeti Road, Ujeti Halol-389350, Gujarat, India. NDC 62756-233-01

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason: Out of specification for assay
Published: May 15, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 13107-283-01, b) 500 tablets per bottle, NDC 13107-283-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.

by Aurobindo Pharma USA Inc.

Reason: Discoloration: Dotted and yellow spots on tablets
Published: May 15, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per bottle, NDC 13107-282-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.

by Aurobindo Pharma USA Inc.

Reason: Discoloration: Dotted and yellow spots on tablets
Published: May 15, 2024
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle, Manufactured for Acela Pharmaceuticals, LLC Alphareta, GA 30005, NDC 42192-136-06

by Acella Pharmaceuticals, LLC

Reason: Subpotent drug
Published: May 15, 2024
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3824-00; (b) 90-count blister pack, NDC 70518-3824-02; (a) 180-count blister pack, NDC 70518-3824-03; RX ONLY, MFG: Advagen Pharma Limited, Plainsboro. NJ 08536, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, 724.465.8762

by RemedyRePack Inc.

Reason: Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count tramadol
Published: May 15, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distributed by: Advagen Pharma Limited, 666 Plainsboro Road Suite 605, Plainsboro, NJ, 08536, USA, Manufactured by: Rubicon Research, Private Limited, Ambernath, Dist. Thane, 421506 India NDC 72888-080-00

by Rubicon Research Private Limited

Reason: Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
Published: May 15, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass I

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 43598-477-30.

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 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 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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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.