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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

Newest recallhttp://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/gf-blends-recalls-truly-aip-all-purpose-flour-and-bread-mix-and-eat-gangster-flat-bread-pizza-mixPublished September 18, 2026

Most affected stateHawaii 200 recalls mention this state

State: PR ×
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Recalls announced by month (Year to date)

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Source: FDA and USDA public dataLast updated September 21, 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

Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 units/gm & 1 mg/gm, packaged in a) 15 g tube (NDC 43598-431-44), b) 30 g tube (NDC 43598-431-30), c) 60 g tube (NDC 43598-431-60), Rx only, Distributor: Dr. Reddy's Laboratories, Inc. 107 College Road East, Princeton, NJ - 08540 Rx Only Made in India

by Dr. Reddy's Laboratories, Inc.

Reason: Failed stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability testing.
Published: October 10, 2018
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Thyroid Powder 25kg/drum, US Pharmacopoeia, Sichuan Friendly Pharmaceutical Co., LTD, Production Address: No. 680, Hongpai Road, Dongxing District, Neijiang City Sichuan, China Tel:+886 832 2240082/2240298. NDC 7807-0170-11

by Sichuan Friendly Pharmaceutical Co.,Ltd.

Reason: CGMP Deviations: Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Published: October 10, 2018
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Elelyso (taliglucerase alfa) for injection, 200 units/vial, single-use vial, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, NDC 0069-0106-01

by Pfizer Inc.

Reason: Lack of assurance of sterility -Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to flip off the orange color plastic button.
Published: October 10, 2018
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

NeoRelief for Muscle Cramping & Restlessness Homeopathic Topical Gel, packaged in a) 4 ml sample packs and b) Net Wt. 2.0 oz (56.7g) bottles, BioLyte Laboratories - Grand Rapids, MI 49534, NDC 58368-002-02

by BioLyte Laboratories, LLC

Reason: CGMP Deviations: finished product produced with active ingredients recalled by the manufacturer, King Bio Inc., due to water contamination issues that could potentially affect the quality of this product.
Published: October 10, 2018
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5416-01 Yellow, round, flat-faced, beveled-edge, unscored tablet. Debossed with 13 on one side and plain on the other side.

by Teva Pharmaceuticals USA

Reason: Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.
Published: October 10, 2018
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Synjardy (empagliflozin and metformin hydrochloride) Tablets. 5 mg/1000 mg. Rx only. 180-count bottle. Distributed by: Boehinger Ingelheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877. Made in Germany. Marketed by: BI Pharmaceuticals, Inc. Ridgefield, CT 06877 and Eli Lilly and Company Indianapolis IN 46285 NDC 0597-0175-18

by Boehringer Ingelheim Pharmaceuticals, Inc.

Reason: Cross Contamination With Other Products:
Published: October 3, 2018
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Levofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in a) 50 mL (NDC 36000-046-24), b) 100 mL (NDC 36000-047-24), c) 150 mL (NDC 36000-048-24) Container bags, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India.

by Baxter Healthcare Corporation

Reason: Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Published: October 3, 2018
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, NDC 31722-726-30.

by Hetero Labs Limited Unit V

Reason: Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.
Published: October 3, 2018
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Minivelle (estradiol transdermal system) Patches, Delivers 0.075 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6675-8

by Noven Pharmaceuticals, Inc.

Reason: Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Published: October 3, 2018
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Minivelle (estradiol transdermal system) Patches, Delivers 0.025 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6625-8

by Noven Pharmaceuticals, Inc.

Reason: Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Published: October 3, 2018
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Minivelle (estradiol transdermal system) Patches, Delivers 0.05 mg/day, a) 2 count and 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6650-8

by Noven Pharmaceuticals, Inc.

Reason: Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Published: October 3, 2018
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Minivelle (estradiol transdermal system) Patches Delivers 0.1 mg/day, a) 2 count and b) 8 count boxes, Rx only, , Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6610-8

by Noven Pharmaceuticals, Inc.

Reason: Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Published: October 3, 2018
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass I

Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manfuactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, NDC 31722-726-30

by Hetero Labs Limited Unit V

Reason: Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.
Published: October 3, 2018
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass III

Swire Coca Cola USA

Product: Caffeine-Free Barq s Root Beer 12 Pack, 12 oz cans
Reason: Recalling Caffeine-Free Barq s Root Beer 12 Pack due to mislabeling.
Published: October 3, 2018
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass II

Swanson Health Products, Inc

Product: Swanson Ultra, Himalayan Crystal Salt, #SWU403, Net Wt. 35.2…
Reason: Himalayan Crystal Salt may contain metal wire pieces.
Published: October 3, 2018
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottle, Rx only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, NDC 43386-541-01

by LUPIN SOMERSET

Reason: Failed Impurities/Degradation Specifications: Morphine Sulfate Extended Release Tablets are being recalled due to out of Specification Result noticed for Morphinone Sulfate impurity during 3 month stability analysis and during retain testing.
Published: September 26, 2018
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Bupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottle (NDC 69097-875-05), Manufactured for: Cipla USA Inc., 1560 Sawgrass Corporate Parkway, Suite 130 Sunrise, FL 33323 b) 90-count bottle (NDC 68001-322-05), For BluePoint Laboratories, Rx only, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788

by InvaGen Pharmaceuticals, Inc.

Reason: Failed impurities/ degradation specifications: Out-of-specification results were observed in the meta-chlorobenzoic acid impurity in batches 18 months or older from date of manufacture in the 90 count bottle size.
Published: September 26, 2018
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx Only, Manufactured in INDIA, For: TORRENT PHARMA INC., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920. NDC: 13668-342-30

by Torrent Pharma Inc.

Reason: Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.
Published: September 26, 2018
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Arthritis Pain Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7042-7

by Beaumont Bio-med, Inc.

Reason: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Published: September 26, 2018
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Colds & Flu Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7012-7

by Beaumont Bio-med, Inc.

Reason: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Published: September 26, 2018
Distribution: Nationwide

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Data last updated: September 21, 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.