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Recall totals

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

37,205

Total recall recordsAll FDA and USDA recalls in Public Health Trace

9,841

Class I recallsReasonable probability of serious health consequences

24,366

Class II recallsTemporary or medically reversible health consequences

2,892

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 2,073 recalls

Newest recallhttp://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/gias-foods-inc-recalls-bettergoods-authentic-italian-lemon-alfredo-fettuccine-because-possible-0Published October 1, 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 October 2, 2026 ET

Summary (Year to date)

1,714 recalls have been announced year to date.
Sep 2026 was 3% higher than the previous complete period (Aug 2026: 182).
The highest complete period was Jun 2026 (297).
Oct 2026 is incomplete and not included in the figures above.

Complete data
Incomplete

Recalls by class

Recalls by class
Class	Recalls
Class II	24,366
Class I	9,841
Class III	2,892
Not Yet Classified	2

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Recalls by class
Class	Recalls
Class II	24,366
Class I	9,841
Class III	2,892
Not Yet Classified	2

FDA Recall Terminated Historical recordClass II

OFIRMEV (acetaminophen) injection, 1000 mg/100 mL (10 mg/mL), 24-count Single Use 100 mL Vials per carton, Rx only, Manufactured for: Cadence Pharmaceuticals, Inc., San Diego, CA 92130, NDC 43825-102-01, UPC 3 43825 10201 7.

by Cadence Pharmaceuticals

Reason: Presence of Particulate Matter: The firm initiated the recall due to visible presence of particulate matter.
Published: August 8, 2012
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL, 16 fl oz (473 mL) bottle, Rx only, Mallinckrodt Inc., Hazelwood, MO 63042 USA, NDC 0406-0375-16, UPC 3 0406-0375-16 1.

by Mallinckrodt Inc.

Reason: CGMP Deviations: This product is being recalled because expired flavoring was used in the manufacturing of these lots.
Published: August 8, 2012
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL, 16 fl oz (473 mL) bottle, Rx only, Mallinckrodt Inc., Hazelwood, MO 63042 USA, NDC 0406-0375-16, UPC 3 0406-0375-16 1.

by Mallinckrodt Inc.

Reason: Subpotent (Multiple Ingredient) Drug: Low out of specification assay results for the hydrocodone bitartrate ingredient was found.
Published: August 8, 2012
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Metformin Hydrochloride Tablets, USP, 1000 mg, Rx only, 1000 count tablets per Bottle, Manufactured by: Cadila Healthcare LTD. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534, NDC 68382-030-10.

by Zydus Pharmaceuticals USA Inc

Reason: Presence of Foreign Substance(s): A product complaint was received from a pharmacist who discovered that several tablets displayed brown specks. The same complainant also reported that metal shaving like material was observed on the surface of one tablet.
Published: August 8, 2012
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Tizanidine (Generic for: Zanaflex), 4 mg, 90 Tablets per Bottle, Rx only, , Mfg By: Dr Reddys Labs Ltd., Bachepally, IN 500 - 090, Packaged and distributed by STAT Rx USA, Gainesville, GA, NDC 16590-221-90.

by Stat Rx USA

Reason: Labeling: Label Mix-Up; Some bottles of Tizanidine 4mg Tablets, had the incorrect manufacturer (Actavis) printed on the label.
Published: August 1, 2012
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Erythromycin Topical Solution USP, 2%, 60 mL bottle with applicator, Rx only. E. FOUGERA & CO., A division of Fougera Pharmaceuticals, Inc., Melville, New York 11747, NDC 0168-0215-60, UPC 3 0168-0215-60 0.

by Fougera Pharmaceuticals, Inc.

Reason: Chemical Contamination: This product is being recalled because trace amounts of a plasticizer (Di-Octyl Phthalate) may be present in the product.
Published: August 1, 2012
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Dent's Extra Strength Toothache Gum, (benzocaine 20%), Net Wt. .035 Oz.. (1 g) box, C.S. Dent & Co., Erlanger, KY

by Grandpa Brands Co

Reason: Superpotent; benzocaine
Published: August 1, 2012
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Ciprofloxacin Tablets, USP, 500 mg, Rx Only, 100 Tablets per Bottle, Manufactured in India by: Unique Pharmaceutical Laboratories (A Division of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai - 400 030, Distributed by: PACK Pharmaceuticals, LLC, Buffalo Grove, IL 60089, NDC 16571-412-10.

by Pack Pharmaceuticals

Reason: Labeling Illegible: Missing Label; The voluntary recall of the aforementioned batch of product is being initiated due to two bottles missing container labels.
Published: July 25, 2012
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Epinephrine Injection, USP, 1:1000 (1 mg/mL), 25 x 1 mL Ampules, For SC and IM Use, For IV and IC Use after Dilution, Rx Only, American Regent, Inc., Shirely, NY 11967 --NDC 0517-1071-25

by Luitpold Pharmaceuticals, Inc.

Reason: Presence of Particulate Matter
Published: July 25, 2012
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Pitocin (Oxytocin Injection, USP) Synthetic 10 units per mL 10 mL, Rx only, Manufactured and Distributed by: JHP Pharmaceuticals, LLC Rochester, MI 48307 NDC 42023-116-02

by JHP Pharmaceuticals, LLC

Reason: Labeling: Label Mix-up: Pitocin storage conditions should be labeled, "Store between 20¿ to 25¿C (68¿ to 77¿F)". Pitocin lot 225867 and part of Pitocin lot 231423 were labeled, "Store between 20¿ to 25¿C (28¿ to 77¿F)".
Published: July 25, 2012
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass I

Morphine Sulfate Injection, USP, 4mg/mL, 1 mL fill in 2.5 mL Carpuject Cartridge Unit with Luer Lock, packaged 10 Carpujects/carton, CII, Rx only, Hospira, Inc., Lake Forest, IL ---- NDC 0409-1258-30

by Hospira Inc.

Reason: Superpotent; Cartridges labeled to contain 1 mL found to contain 2.2 mL
Published: July 25, 2012
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Prefera OB One Gel Capsules, 30 softgels, Rx Only, Manufactured by: IVC industries, Inc. Irving ton, NJ 07111, For: Alaven Pharmaceutical LLC Marietta, GA 30062, NDC 68220-086-30

by Meda Pharmaceuticals Inc.

Reason: Labeling: Presence of Undeclared Color Additive; The product is being recalled because several inactive ingredients were not included in the labeling for this product: Undeclared D&C Red #33, FD&C Blue #1, Titanium Dioxide Suspension, Purified Water USP.
Published: July 25, 2012
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION, USP, 10 mg/5 mL, 1 PINT (473 mL) bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-1310-58, UPC 3 0603-1310-58 4.

by Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals

Reason: Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-month room temperature time point.
Published: July 25, 2012
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Hydrocodone Bitartrate & Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL, a) 15 mL Unit Dose Cups (50 unit dose cups per case), b) 473 mL Bottles, C III, Rx Only, Warning May be habit forming, Manufactured by VistaPharm, Largo, FL 33771, NDC a) 66689-023-50, b) NDC 66689-023-16.

by VistaPharm, Inc.

Reason: Impurities/Degradation Products: exceeded specification at 3 month stability testing
Published: July 18, 2012
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Kleenex Foam Hand Sanitizer, Alcohol Free in a) 1.5 fl oz. (45mL) , b) 8 fl oz. (236mL) , and c) 16 fl oz (473mL) bottles, Distributed by Kimberly Clark, LLC, Roswell, GA 30076

by Kimberly-Clark Corporation

Reason: Microbial Contamination of Non-Sterile Products; The affected lots were found to be contaminated with bacterium, Burkholderia cepacia complex.
Published: July 18, 2012
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Kleenex Luxury Foam Hand Sanitizer, (Benzalkonium Chloride 0.1%), in a) 1 Liter (33.8 fl oz.), b) 1.2 Liters (40.5 fl oz.) Cassettes, Distributed by Kimberly Clark, LLC, Roswell, GA 30076

by Kimberly-Clark Corporation

Reason: Microbial Contamination of Non-Sterile Products; The affected lots were found to be contaminated with bacterium, Burkholderia cepacia complex.
Published: July 18, 2012
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Daytrana (Methylphenidate) Transdermal System Patch, Delivers 20 mg over 9 hours (2. 2 mg/hr), 1 patch per pouch (NDC 68968-5554-01) packaged in 3-count patches per box (NDC 68968-5554-3) , Rx only, Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33816.08/04/12.

by Noven Pharmaceuticals, Inc.

Reason: Miscalibrated/Defective Delivery System; exceeded the specification for both mechanical peel force (MPF) and/or the z-statistic value
Published: July 18, 2012
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Trizivir (abacavir sulfate 300mg, lamivudine 150 mg and zidovudine 300 mg), 60 Tablets, Rx only, Manufactured for: ViiV Healthcare, Research Triangle Park, NC 27709 by: GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 49702-217-18

by GlaxoSmithKline Inc

Reason: Adulterated Presence of Foreign Tablets: Trizivir 300/150/300 mg tables, Lot 0ZP5128 may incorrectly contain Lexiva 700 mg tablets.
Published: July 18, 2012
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

HYDROCORTISONE and ACETIC ACID OTIC SOLUTION, USP, 10 mL bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811; NDC 0603-7039-39; UPC 3 0603-7039-39 7.

by Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals

Reason: Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month room temperature time point.
Published: July 18, 2012
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Nexium (esomeprazole magnesium) Delayed-Release Capsules, 40 mg, 1000-count bottle, Rx only, Manufactured for: AstraZeneca LP, Wilmington, DE 19850; By: AstraZeneca AB, S-151 85 Sodertalje, Sweden, NDC 0186-5040-85, UPC 3 0186-5040-85 0.

by ASTRA ZENECA Lp

Reason: Adulterated Presence of Foreign Tablets/Capsules: Some bottles may contain a small number of Nexium 20 mg capsules intended for the Japanese market in addtion to Nexium 40 mg capsules.
Published: July 18, 2012
Distribution: Nationwide

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Data last updated: October 2, 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.