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Recall totals

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

37,118
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
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)

  • 1,527 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

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

Recalls by class
ClassRecalls
Class II24,343
Class I9,793
Class III2,887
Not Yet Classified1
Download CSV
Recalls by class
ClassRecalls
Class II24,343
Class I9,793
Class III2,887
Not Yet Classified1

Showing 9,741–9,760 of 17,327 recalls

FDA Recall United States Terminated Historical recordClass III

Bestco, Inc.

Product
Signature Care Calcium Chews; Dietary Supplement; 500 mg Cal…
Reason
A packaging revision and lack of revision to the corresponding packaging batch record caused the labeling for the firm's Signature Care brand Calcium Chews dietary supplement to declare a higher level of Vitamin D than the product actually contained. The bag declares 25 mcg (1000 IU) of Vitamin D. The product actually contains 12.5 mcg (500 IU) of Vitamin D.
Published
April 18, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC 69097-878-03) and b) 100 count (NDC 69097-878-07) bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560 Sawgrass Corporate Parkway Suite 130 Sunrise, FL 33323, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788

by InvaGen Pharmaceuticals, Inc.

Reason
Failed Dissolution Specifications; during stability testing
Published
April 11, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560 Sawgrass Corporate Parkway Suite 130 Sunrise, FL 33323, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788 --- NDC 69097-877-03

by InvaGen Pharmaceuticals, Inc.

Reason
Failed Dissolution Specifications; during stability testing
Published
April 11, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Fabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834; NDC 51862-295-10.

by Mayne Pharma Inc

Reason
Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point.
Published
April 11, 2018
Distribution
Nationwide

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FDA Recall United States Terminated Historical recordClass I

Natural Grocers by Vitamin Cottage

Product
Natural Grocers Organic Coconut Smiles, 10 oz. plastic resea…
Reason
Coconut smiles product tested positive for Salmonella.
Published
April 11, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

24-HOUR Oral Care q4 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cup (NDC 50383-720-15), Rx Only, Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701; Kit Manufactured by Halyard Health, Inc., 5405 Windward Parkway, Alpharetta, GA 30004; Distributed in the USA by Halyard Sales, LLC, Alpharetta, GA 30004, Product 97014.

by Akorn, Inc.

Reason
Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Published
April 4, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

24-HOUR Oral Care q2 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cup (NDC 50383-720-15), Rx Only, Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701; Kit Manufactured by Halyard Health, Inc., 5405 Windward Parkway, Alpharetta, GA 30004; Distributed in the USA by Halyard Sales, LLC, Alpharetta, GA 30004, Product 97012.

by Akorn, Inc.

Reason
Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Published
April 4, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups (NDC 50383-720-15) packaged in 100-count (10 x 10) cups per case pack (NDC 50383-720-18 or 50383-720-19), Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701.

by Akorn, Inc.

Reason
Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Published
April 4, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807, NDC 70121-1390-1

by Amneal Pharmaceuticals

Reason
Presence of particulate matter
Published
April 4, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Evamist (estradiol transdermal spray), 1.53mg estradiol/spray, 0.27 fl oz (8.1 mL) per bottle, Rx Only, Manufactured for Perrigo, Minneapolis, MN 55427. NDC: 0574-2067-27

by Paddock Laboratories, LLC.

Reason
Defective Delivery System: Potential that cracks in the vial neck near the crimp may result in product evaporation and/or leaking and the inability to properly dispense product.
Published
April 4, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Indomethacin Capsules USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-302-01.

by Glenmark Pharmaceuticals Inc., USA

Reason
Labeling: Incorrect Instructions: bottles incorrectly labeled with the usual adult dosage of "One or two capsules 2 or 3 times a day." rather than the correct usual adult dosage of "One capsule 2 or 3 times a day.
Published
April 4, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flexible Containers, Rx Only, Manufactured for: Claris Lifesciences, Inc. North Brunswick, NJ 08902 By; Claris Injectables Ltd. Gujarat, India --- NDC 36000-006-10

by Renaissance Lakewood, LLC

Reason
Superpotent and Failed Stability Specifications; out of specification results for assay and water vapor permeability
Published
April 4, 2018
Distribution
Nationwide

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FDA Recall United States Ongoing Historical recordClass I

Piggie Park Enterprises Inc

Product
Maurice's Honey Southern Gold BBQ Sauce; Net Wt. 18 oz. bott…
Reason
Undeclared soy and wheat ingredients
Published
April 4, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Triamcinolone Acetonide Lotion, USP 0.1%, 60 mL bottle, Rx Only, Marketed by: VersaPharm Incorporated, Marietta, GA 30062; Manufactured by: Ei LLC, Kannapolis, NC 28083, NDC 61748-220-60.

by Akorn, Inc.

Reason
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Published
March 28, 2018
Distribution
Nationwide

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FDA Recall United States Terminated Historical recordClass III

Ikea North America Srvcs Inc

Product
Pink flexible, plastic package: Godis Paskkyckling Marshm…
Reason
Possible Pest Contamination at production facility.
Published
March 28, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Valacyclovir Tablets USP 1 gram, 30-count bottle, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs Limit Unit V Pollypally Jadcherla Mahaboob Nagar - 509 301 India NDC # 31722-705-30

by Hetero Labs Limited Unit V

Reason
Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018).
Published
March 21, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Valganciclovir Tablets, USP, 450 mg, 60-count bottle, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, By: Hetero Hetero Labs Limit Unit V Pollypally Jadcherla Mahaboob Nagar - 509 301 India. NDC # 31722-832-60

by Hetero Labs Limited Unit V

Reason
Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018).
Published
March 21, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5 mg Rx Only 30 Tablets Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-118-03 UPC 343386118038

by Novel Laboratories, Inc.

Reason
Failed Impurities/Degradation Specifications
Published
March 21, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Clocortolone Pivalate Cream, 0.1%, 90-gram tube, Rx only, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, Manufactured by: DPT, Laboratories Ltd. San Antonio, TX 78215, NDC 43598-341-90

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Stability Specifications:Out-of-specification results observed for viscosity during stability testing.
Published
March 21, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Hospira, Inc., Lake forest, IL 60045 USA. NDC: 0409-2634-01

by Pfizer Inc.

Reason
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
Published
March 21, 2018
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.