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Recall totals

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

37,211
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
Most affected stateHawaii 200 recalls mention this state

Download matching recalls as CSV

CSV exports include up to 5,000 matching rows (applying your current filters), not the full dataset if it's larger.

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Recalls announced by month (Year to date)

A chart of recalls grouped by month.

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Source: FDA and USDA public dataLast updated

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

A bar chart of the total number of recalls in this dataset by recall class.

Recalls by class
ClassRecalls
Class II24,366
Class I9,841
Class III2,892
Not Yet Classified2
Download CSV
Recalls by class
ClassRecalls
Class II24,366
Class I9,841
Class III2,892
Not Yet Classified2

Showing 18,521–18,540 of 18,578 recalls

FDA Recall Terminated Historical recordClass I

HYDROmorphone HCl Injection, USP, 1 mg/mL, 1 mL fill in a 2.5 mL Carpuject prefilled cartridge unit, packaged in 10-count Carpujects per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1283-31, Barcode (01) 1 030409 128331 9 (carton), (01) 0 030409 128331 2 (cartridge unit).

by Hospira Inc.

Reason
Superpotent (Single Ingredient) Drug: Some of the prefilled cartridge units have been found to be overfilled and contain more than the 1 mL labeled fill volume.
Published
August 15, 2012
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Meloxicam Tablets, USP, 15 mg, Rx Only, 100 Tablets per Bottle, Manufactured by: Strides Acrolab Ltd., Bangalore-560 076, India, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-3579-1.

by Apotex Corp.

Reason
Tablet Thickness: Recall was initiated due to the presence of one slightly oversized tablet in a bottle of the identified lot.
Published
August 15, 2012
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Copaxone (glatiramer acetate injection), 20mg/mL, 1 mL , Rx only, Marketed by: Teva Neuroscience - NDC 68546-317-30

by Teva Pharmaceuticals USA, Inc.

Reason
Presence of Foreign Substance: Recall is being initiated due to the presence of a foreign particle identified from a customer complaint.
Published
August 15, 2012
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, supplied in 5 mL unit dose cups, VISTAPHARM, Largo, FL NDC 66689-036-50

by VistaPharm, Inc.

Reason
Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and assay failures were due to the loss of moisture. The loss of moisture caused the viscosity to increase and assay to increase relative to the sample volume.
Published
August 8, 2012
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Dorzolamide HCI/Timolol Maleate Ophthalmic Solution 22.3mg/6.8mg per mL, 10mL bottle, For Topical Application in the Eye, Sterile Ophthalmic Solution, Rx Only, Mfg by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9

by Apotex Inc.

Reason
Presence of Particulate Matter: Lots identified in this recall notification may contain small particulates.
Published
August 8, 2012
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen), 0.1 mg/0.025 mg, 0.125 mg/0.025 mg, 0.15 mg/0.025 mg, 28-count tablets per dispenser (NDC 52544-959-28), packaged in 3-count Tablet Dispensers per carton (NDC 52544-959-31), Rx only Manufactured by: Watson Laboratories, Inc., Corona, CA 92880; Distributed by: Watson Pharma, Inc., Corona, CA 92880.

by Watson Laboratories Inc

Reason
Impurities/Degradation Products: High Out-of-specification results were obtained for both known and unknown impurities.
Published
August 8, 2012
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Dr. Reddy's Ciprofloxacin Tablets, USP 500 mg*, 500 Tablets, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325 INDIA, NDC 55111-127-05

by Dr. Reddy's Laboratories, Inc.

Reason
Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of mislabeled bottles of Amlodipine Besylate and Benazepril Hydrochloride Capsules and Ciprofloxacin Tablets
Published
August 8, 2012
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Dr. Reddy's Amlodipine Besylate and Benazepril Hydrochloride 5 mg*/20 mg, 500 Capsules, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325 INDIA, NDC 55111-340-05

by Dr. Reddy's Laboratories, Inc.

Reason
Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of mislabeled bottles of Amlodipine Besylate and Benazepril Hydrochloride Capsules and Ciprofloxacin Tablets.
Published
August 8, 2012
Distribution
Nationwide

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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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Data last updated:

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.