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Recall totals

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

37,113

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/whole-foods-market-issues-allergy-alert-undeclared-egg-cabricharme-cheesePublished September 11, 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 15, 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

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 Terminated Historical 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 Completed Historical 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 Completed Historical 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 Completed Historical 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 Completed Historical 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 Terminated Historical 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 Terminated Historical 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 Ongoing Historical 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 Ongoing Historical 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 Ongoing Historical 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 Ongoing Historical 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 Terminated Historical 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 Terminated Historical 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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FDA Recall Terminated Historical recordClass II

Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, packaged in a) 30 mL bottle (NDC 61748-480-30), b) 60 mL bottle (NDC 61748-480-60), Rx only, Manufactured by: Hi-Tech Pharmacal Co. Inc., Amityville,NY 11701

by Akorn, Inc.

Reason: Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product.
Published: September 22, 2021
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Glycopyrrolate Injection, USP 4mg per 20mL, 20 mL Multi-Dose Vials, Rx only, Mfd for Meitheal Pharmaceuticals, Chicago, IL 60631. NDC 71288-408-21

by Meitheal Pharmaceuticals Inc

Reason: Failed Impurities/Degradation Specifications
Published: September 22, 2021
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass I

Lidocaine Hydrochloride Topical Solution, USP, 4% , 50 mL glass bottles, Rx Only, Teligent Pharma Inc. Buena, New Jersey 08310, NDC 52565-009-50.

by Teligent Pharma, Inc.

Reason: Superpotent Drug
Published: September 22, 2021
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Kroger 70% Isopropyl Alcohol First Aid Antiseptic 32 FL OZ (1 QT) 946 mL 5 Dist. By The Kroger Co., Cincinnati, Ohio 45202 NDC 30142-810-45, UPC 0 11110 37049

by Vi-Jon, Inc.

Reason: Labeling: Label Mix-Up.The recall has been initiated after receiving one complaint about incorrect labeling.The primary label on the front and back label on some of the bottles have 70% Isopropyl Alcohol affixed to the containers. However, the product inside the bottle is Hydrogen Peroxide, Topical Solution USP with active ingredient Hydrogen Peroxide (stabilized) 3%, 32 FL Ounces
Published: September 22, 2021
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-3231-93

by Viatris

Reason: Failed Impurities/Degradation Specifications; out of specification for Related Compound
Published: September 22, 2021
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass I

Hydro Pinapple Burn Max Health Thach Dua, packaged in a box containing 20g x 10 goi/sachets, MATXI CORP, UPC 8 936188 880108

by Ebay Seller - John Nguyen

Reason: Marketed without an approved NDA/ ANDA - presence of undeclared sibutramine
Published: September 22, 2021
Distribution: Nationwide

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Data last updated: September 15, 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.