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Recall totals

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

37,116

Total recall recordsAll FDA and USDA recalls in Public Health Trace

9,793

Class I recallsReasonable probability of serious health consequences

24,343

Class II recallsTemporary or medically reversible health consequences

2,887

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/saratoga-potato-chips-issues-allergy-alert-undeclared-soy-j-higgs-loaded-bacon-and-cheddar-potatoPublished September 16, 2026

Most affected stateHawaii 200 recalls mention this state

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

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Source: FDA and USDA public dataLast updated September 18, 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	24,343
Class I	9,793
Class III	2,887
Not Yet Classified	1

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Recalls by class
Class	Recalls
Class II	24,343
Class I	9,793
Class III	2,887
Not Yet Classified	1

FDA Recall Terminated Historical recordClass II

Equate Night-time Sleep Aide (Diphenhydramine HCl), 50 mg, Alcohol Free, Berry Flavor, 12 Fl. Oz. (354 mL), OTC, Distributed by: Walmart Stores, Inc., Bentonville, AR 72716, NDC 49035-330-02, UPC 6 8113117595 1

by LNK International, Inc.

Reason: Microbial contamination of non-sterile product
Published: August 7, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose carton, RX only, Manufactured by Dr. Reddy's Laboratories Ltd. Bachupally - 500 090 India. Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152. NDC # 0904-6363-61.

by MAJOR PHARMACEUTICALS

Reason: cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Published: August 7, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10 Unit Dose Blisters), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio, 43217, NDC Carton: 62584-693-21; NDC Unit Dose: 62584-693-11

by American Health Packaging

Reason: Failed Dissolution Specifications: Out of specification result for the dissolution test.
Published: August 7, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Timolol- Dorzolamide- Latanoprost P-F (0.5/2.0/0.005%) ophthalmic drops, packaged in 5mL bottles, Rx only, ImprimisRx NJ 1705 Route 46 West, Suite 4, Ledgewood, NJ 07852 (844) 446-6979

by ImprimisRx NJ

Reason: Subpotent Drug
Published: August 7, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Timolol-Latanoprost P-F (0.5/0.005%) ophthalmic drops, packaged in 5mL bottles, Rx only, ImprimisRX NJ 1705 Route 46 West, Suite 4, Ledgewood, NJ 07852 (844) 446-6979

by ImprimisRx NJ

Reason: Subpotent Drug
Published: August 7, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Kaitlib Fe norethindrone and ethinyl estradiol chewable tablets (0.8 mg/0.025 mg) and Ferrous Fumarate, Chewable Tablets, Rx Only, Distributed by: Lupin Pharmaceuticals, Inc. Baltimore, MD - 21202 Manufactured by: Lupin Limited Pathampur -454775 India. NDC 68180-903-11 (wallet of 28 tablets) NDC 68180-903-13 (carton of 3 wallets)

by Lupin Pharmaceuticals Inc.

Reason: Failed Impurities/Degradation Specifications: Kaitlib Fe Tablets has an out of specification result observed in long term stability study.
Published: August 7, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg, 500-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA, NDC 68180-519-02

by Lupin Pharmaceuticals Inc.

Reason: Presence of Foreign Tablets/Capsules: Product complaint received of one Fenofibrate tablet 145mg observed in 500 s count product bottle.
Published: July 31, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

MONSEL'S (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with applicators per box, Rx only, Gordon Laboratories, Upper Darby, PA 19082, NDC 10481-0112-8.

by Dercher Enterprises, Inc., DBA Gordon Laboratories

Reason: Microbial Contamination of Non-Sterile Products and Superpotent Drug: FDA analysis revealed microbial contamination in addition to high out of specification results for iron content.
Published: July 31, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Preferred Plus Dioctyl Liquid Stool Softener (Docusate Sodium), 50mg/5mL, 16 FL. Oz. (1 PT.) 473 mL, Manufactured by RIJ Pharmaceutical Corp. 40 Commercial Avenue Middletown, NY 10941, Distributed by Kinray Inc. Whitestone, NY 11357, NDC 53807-216-16

by Geritrex, LLC

Reason: cGMP Deviations: Products may have microbial contamination.
Published: July 31, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Gericare Geri-Tussin DM, 16 FL OZ (473 mL), Geri-care Phamaceuticals Corp. 1650 63rd Street Brooklyn, NY, NDC 57896-660-16

by Geritrex, LLC

Reason: cGMP Deviations: Products may have microbial contamination.
Published: July 31, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Ritussin DM Double Strength, 4 FL. OZ. (118 mL), RIJ Pharmaceutical Corporation 40 Commercial Avenue Middletown, NY 10941

by Geritrex, LLC

Reason: cGMP Deviations: Products may have microbial contamination.
Published: July 31, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Preferred Plus Pharmacy Iron Elixir Ferrous Sulfate, 220 mg, 16 fl oz. (473 mL), Distributed by: Geri-care Pharmaceuticals Corp. 1650 63rd Street Brooklyn, NY 11204, NDC 52807-177-16

by Geritrex, LLC

Reason: cGMP Deviations: Products may have microbial contamination.
Published: July 31, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Gericare Iron Supplement Elixir Ferrous Sulfate, 220 mg, 16 fl oz. (473 mL), Distributed by: Geri-care Pharmaceuticals Corp. 1650 63rd Street Brooklyn, NY 11204, NDC 57896-709-16

by Geritrex, LLC

Reason: cGMP Deviations: Products may have microbial contamination.
Published: July 31, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Gericare Diocto Liquid Docusate Sodium Stool Softener, 50 mg/5mL, 16 FL OZ (473 ml), Dist. BY: Gericare Pharmaceuticals corp. 1650 63rd Street Brooklyn, NY 11204, NDC 57896-403-16

by Geritrex, LLC

Reason: cGMP Deviations: Products may have microbial contamination.
Published: July 31, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Ritussin DM Children & Adults, 4 Fl. Oz. (118 mL), RIJ Pharmaceutical Corporation 40 Commercial Avenue Middletown, NY 10941, NDC 53807-409-04

by Geritrex, LLC

Reason: cGMP Deviations: Products may have microbial contamination.
Published: July 31, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Diphenhydramine Oral Liquid Alcohol Free, 12.5 mg/5 mL, 4 fl oz (118 mL), RIJ Pharmaceutical Corporation 40 Commercial Avenue Middletown, NY 10941, NDC 53807-204-04

by Geritrex, LLC

Reason: cGMP Deviations: Products may have microbial contamination.
Published: July 31, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Clobazam Oral Suspension, 2.5 mg/mL, 120 mL bottle, Rx only, Distributed by: Bionpharma Inc., 600 Alexander Road, Princeton, NJ 08540, NDC 69452-116-45.

by Bionpharma Inc.

Reason: Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed.
Published: July 31, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Nystatin and Triamcinolone Acetonide Cream USP100,000 units/g, 0.1%, 15 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 INDIA, NDC 68180-545-01

by Lupin Pharmaceuticals Inc.

Reason: Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers test at 9 month long term stability condition for upright orientation.
Published: July 31, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, (equivalent to 10 mg hydrocodone bitartrate and 8 mg chlorpheniramine maleate per 5 mL), 16 fl. oz. (473 mL) bottle, Rx only, Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852, NDC 27808-086-02.

by Tris Pharma Inc.

Reason: Superpotent Drug and Failed Stability Specifications: High out-of-specification results for the active ingredients, hydrocodone and chlorpheniramine, as well as high out-of-specification results for the preservatives.
Published: July 31, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) and b) 28 count bottles (NDC 69238-1605-08)

by Amneal Pharmaceuticals, Inc.

Reason: Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergonovine Maleate tablets
Published: July 31, 2019
Distribution: Nationwide

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Data last updated: September 18, 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.