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Recall totals

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

37,326

Total recall recordsAll FDA and USDA recalls in Public Health Trace

9,859

Class I recallsReasonable probability of serious health consequences

24,440

Class II recallsTemporary or medically reversible health consequences

2,900

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 2,095 recalls

Newest recallhttp://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/winco-foods-llc-issues-allergy-alert-undeclared-sesame-hoagie-rollsPublished October 22, 2026

Most affected stateHawaii 200 recalls mention this state

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

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Source: FDA and USDA public dataLast updated October 23, 2026 ET

Summary (Year to date)

1,739 recalls have been announced year to date.
Sep 2026 was 15% higher than the previous complete period (Aug 2026: 182).
The highest complete period was Jun 2026 (300).
Oct 2026 is incomplete and not included in the figures above.

Complete data
Incomplete

Recalls by class

Recalls by class
Class	Recalls
Class II	24,440
Class I	9,859
Class III	2,900
Not Yet Classified	2

Recalls by class
Class	Recalls
Class II	24,440
Class I	9,859
Class III	2,900
Not Yet Classified	2

FDA Recall TerminatedTerminated: October 4, 2023Historical recordClass II

Arformoterol Tartrate Inhalation Solution 15 mcg*/2 mL For Oral Inhalation Only Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 60x2 mL Sterile Unit-Dose Vials NDC 68462-833-65; b) 30x2 mL Sterile Unit-Dose Vials NDC 68462-833-35

by Glenmark Pharmaceuticals Inc., USA

Reason: Lack of Assurance of Sterility
Published: September 29, 2021
Distribution: Nationwide

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FDA Recall TerminatedTerminated: October 4, 2023Historical recordClass II

Zonisamide Capsules USP 100 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 100 Capsules NDC 68462-130-01; b) 500 Capsules NDC 68462-130-05

by Glenmark Pharmaceuticals Inc., USA

Reason: CGMP Deviations
Published: September 29, 2021
Distribution: Nationwide

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FDA Recall TerminatedTerminated: October 4, 2023Historical recordClass II

Zonisamide Capsules USP 50 mg 100 Capsules Rx Only NDC 68462-129-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430

by Glenmark Pharmaceuticals Inc., USA

Reason: CGMP Deviations
Published: September 29, 2021
Distribution: Nationwide

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FDA Recall TerminatedTerminated: October 4, 2023Historical recordClass II

Chlorzoxazone Tablets USP 750 mg 100 Tablets Rx Only NDC 68462-725-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430

by Glenmark Pharmaceuticals Inc., USA

Reason: CGMP Deviations
Published: September 29, 2021
Distribution: Nationwide

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FDA Recall TerminatedTerminated: October 4, 2023Historical recordClass II

Chlorzoxazone Tablets USP 375 mg 100 Tablets Rx Only NDC 68462-724-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430

by Glenmark Pharmaceuticals Inc., USA

Reason: CGMP Deviations
Published: September 29, 2021
Distribution: Nationwide

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FDA Recall TerminatedTerminated: October 4, 2023Historical recordClass II

Naproxen Sodium Tablets, USP 550 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 100 Tablets NDC 68462-179-01; b) 500 Tablets NDC 68462-179-05

by Glenmark Pharmaceuticals Inc., USA

Reason: CGMP Deviations
Published: September 29, 2021
Distribution: Nationwide

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FDA Recall TerminatedTerminated: October 4, 2023Historical recordClass II

Naproxen Sodium Tablets, USP 275 mg 100 Tablets Rx Only NDC 68462-178-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430

by Glenmark Pharmaceuticals Inc., USA

Reason: CGMP Deviations
Published: September 29, 2021
Distribution: Nationwide

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FDA Recall TerminatedTerminated: October 4, 2023Historical recordClass II

Fulvestrant Injection 250 mg/5 mL (50 mg/mL) For Intramuscular Use Only Contains 2 single-dose pre-filled syringes Rx only NDC 68462-317-32

by Glenmark Pharmaceuticals Inc., USA

Reason: Lack of Assurance of Sterility
Published: September 29, 2021
Distribution: Nationwide

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FDA Recall CompletedHistorical recordClass I

X RATED HONEY FOR MEN, packaged in 15g packets, 4 packets per box, UPC 6 13682 41232 2

by Phe Inc

Reason: Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.
Published: September 29, 2021
Distribution: Nationwide

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FDA Recall CompletedHistorical recordClass II

Valproic Acid Oral Solution USP, (250 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-621-16

by Morton Grove Pharmaceuticals, Inc.

Reason: CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Published: September 29, 2021
Distribution: Nationwide

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FDA Recall CompletedHistorical recordClass II

Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/5mL & Codeine Phosphate 10 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-606-16

by Morton Grove Pharmaceuticals, Inc.

Reason: CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Published: September 29, 2021
Distribution: Nationwide

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FDA Recall CompletedHistorical recordClass II

Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-608-16

by Morton Grove Pharmaceuticals, Inc.

Reason: CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Published: September 29, 2021
Distribution: Nationwide

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FDA Recall TerminatedTerminated: August 25, 2022Historical recordClass III

Sirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only, Packaged and Distributed by: American Health Packaging Columbus, OH 43217, NDC 68084-915-25

by American Health Packaging

Reason: Failed Impurities/Degradation Specifications
Published: September 29, 2021
Distribution: Nationwide

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FDA Recall TerminatedTerminated: October 31, 2023Historical recordClass II

Metoprolol Tartrate Tablets USP 100 mg, 1000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Highstown Road East Windsor, NJ 08520, NDC 65862-064-99

by Aurobindo Pharma USA Inc.

Reason: Presence of Foreign Substance: Product complaints received for the presence of metal wire in one tablet.
Published: September 29, 2021
Distribution: Nationwide

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FDA Recall OngoingHistorical recordClass II

Chantix (varenicline) tablets 1 mg, Carton containing 4 blister packs of 14 tablets each,, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0469-03. EXPIRATION DATE: September 2021 June 2023

by Pfizer Inc.

Reason: CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Published: September 29, 2021
Distribution: Nationwide

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FDA Recall OngoingHistorical recordClass II

Chantix (varenicline) tablets 1 mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0469-56.

by Pfizer Inc.

Reason: CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Published: September 29, 2021
Distribution: Nationwide

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FDA Recall OngoingHistorical recordClass II

Chantix (varenicline) tablets 0.5mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0468-56.

by Pfizer Inc.

Reason: CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Published: September 29, 2021
Distribution: Nationwide

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FDA Recall OngoingHistorical recordClass II

Chantix (varenicline) tablets 0.5mg/1mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 00069-0471-03. carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42.1 mg tablets.

by Pfizer Inc.

Reason: CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Published: September 29, 2021
Distribution: Nationwide

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FDA Recall TerminatedTerminated: July 12, 2023Historical recordClass I

AMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL in flexible containers, Rx ONLY, Hospira, Inc., Lake Forest, IL 60045. NDC 0409-7171-17

by ICU Medical Inc

Reason: Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples.
Published: September 22, 2021
Distribution: Nationwide

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FDA Recall TerminatedTerminated: August 15, 2023Historical recordClass II

Spironolactone Ophthalmic Solution 0.005 mg/mL, 15 mL bottles, Rx only, Greenpark Compounding Pharmacy

by Prescription Labs Inc dba Greenpark

Reason: Lack of Assurance of Sterility
Published: September 22, 2021
Distribution: Nationwide

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Data last updated: October 23, 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.