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Recall totals

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

37,066

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 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: AS ×
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Recalls announced by month (Year to date)

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Source: FDA and USDA public dataLast updated September 14, 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

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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FDA Recall Terminated Historical recordClass II

Florance Morris ANTISEPTIC Hand Sanitizer (ethyl alcohol 70%), packaged in a) 8.45 fl oz (250 mL) bottles and b) 33.81 fl oz (1L) bottles, Distributed by: Asimex International LLC, 9100 S Dadeland Blvd, Ste 912, Miami, FL 33156, COUNTRY OF ORIGIN: MEXICO.

by Grupo Asimex de Mexico SA de CV

Reason: CGMP Deviations: All other lots are being recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
Published: September 22, 2021
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass I

Florance Morris ANTISEPTIC Hand Sanitizer (ethyl alcohol 70%), packaged in a) 8.45 fl oz (250 mL) bottles and b) 33.81 fl oz (1L) bottles, Distributed by: Asimex International LLC, 9100 S Dadeland Blvd, Ste 912, Miami, FL 33156, COUNTRY OF ORIGIN: MEXICO.

by Grupo Asimex de Mexico SA de CV

Reason: Chemical Contamination: FDA analysis found the product contains methanol, additionally it is sub-potent for ethanol content.
Published: September 22, 2021
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Oxycodone Hydrochloride Tablets, USP, 10 mg, 100 count bottle, Rx only, Marketed by: Rhodes Pharmaceuticals L.P., Coventry RI 02816, Manufactured by: Purdue Pharma L.P., Stanford, CT 06901 NDC 42858-002-01

by Rhodes Pharmaceuticals, L.P.

Reason: Presence of Foreign Tablets/Capsules; A single foreign tablet Hydrochlorothiazide/Lisinopril 25/20 was found in one bottle
Published: September 22, 2021
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

aulief (Organic Camphor 3.00% Organic Menthol 5.00%), topical pain relief, packaged as a) 3.2 oz (90.7g) tube UPC 6 87806 30003 1 NDC 76305-302-01 ; b) 7.0 oz (198.5g) tube, UPC 6 87806 30007 9, NDC 76305-302-02; c) 16 oz (453.6g)Bottle w/ Pump, UPC 6 87806 30016 1, NDC 76305-302-03; Distributed by: CHINA-GEL LLC, Arlington Heights, IL 60005,

by China Gel Inc

Reason: CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
Published: September 8, 2021
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

CHINA-GEL WHITE (Camphor 3.00%, Menthol 5.00%), A TOPICAL PAIN RELIEVER, packaged in a) 2 oz(56.8g) Tube, 76305-301-13 ; b) 4 oz (113.5 g) jar, UPC 6 87806 20004 1, NDC 76305-301-02 ; c) 6 OZ (170 g) tube, UPC 6 87806 20006 5, NDC 76305-301-03; d) 8 oz (226.8 g) Jar, UPC 6 87806 20008 9, NDC 76305-301-04; e) 16 oz ( 453.6 g) Bottle w/ Pump, UPC 6 87806 20016 4, NDC 76305-301-05; f) 120 oz (3.78L) gallon, UPC 6 87806 20128 4, NDC 76305-301-06: Distributed by: CHINA-GEL LLC, Arlington Heights, IL 60005,

by China Gel Inc

Reason: CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
Published: September 8, 2021
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

CHINA_GEL (Camphor 3.00%, Menthol 5.00%) A TOPICAL PAIN RELIEVER, packaged as a) 2 OZ (56.8g) tube, NDC 76305-300-13; b) 4 OZ (113.5g) jar, UPC 6 87806 10004 2, NDC 76305-300-02; c) 6 OZ (170 g) tube, UPC 6 87806 10006 2, NDC 76305-300-03; d) 8 OZ (226.8g) jar, UPC 6 87806 10008 2, NDC 76305-300-04; e) 16 OZ (453.6g), Bottle w/ Pump, UPC 6 87806 10016 7, NDC 76305-300-03; f) 128 OZ (3.78L) Gallon, UPC 6 87806 10128 7, NDC 76305-300-06; Distributed by: CHINA-GEL LLC, Arlington Heights, IL 60005,

by China Gel Inc

Reason: CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
Published: September 8, 2021
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Clopidogrel Tablets, USP, 75 mg, 500-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceutical Ltd., Baddi, Himachal, Pradesh, INDIA NDC 33342-060-15

by Macleods Pharma Usa Inc

Reason: Presence of foreign matter
Published: September 8, 2021
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Artificial Tears Ointment, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-062-35

by Akorn, Inc.

Reason: Non-Sterility - OOS sterility testing observed during 12-month controlled room temperature stability testing. The microbiological investigation identified the organism as a member of the Bacillus cereus group.
Published: September 8, 2021
Distribution: Nationwide

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Data last updated: September 14, 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.