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Recall totals

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

36,950

Total recall recordsAll FDA and USDA recalls in Public Health Trace

9,732

Class I recallsReasonable probability of serious health consequences

24,263

Class II recallsTemporary or medically reversible health consequences

2,873

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 2,071 recalls

Newest recallhttp://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/made-fresh-salads-inc-recalls-ready-eat-deli-style-salads-and-cream-cheese-because-possible-healthPublished September 6, 2026

Most affected stateHawaii 200 recalls mention this state

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

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Source: FDA and USDA public dataLast updated September 7, 2026 ET

Summary (Year to date)

1,458 recalls have been announced year to date.
Aug 2026 was 53% 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	24,263
Class I	9,732
Class III	2,873
Not Yet Classified	1

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Recalls by class
Class	Recalls
Class II	24,263
Class I	9,732
Class III	2,873
Not Yet Classified	1

FDA Recall Ongoing Historical recordClass II

Major ChlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7132-61, UPC (01)00309047132614

by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Reason: CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Published: October 15, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7131-61, UPC (01)00309047131617

by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Reason: CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Published: October 15, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7130-61, UPC (01)00309047130610

by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Reason: CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Published: October 15, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7130-06, UPC (01)00309047130061

by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Reason: CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Published: October 15, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 25 x 10 mL Multiple-Dose Vials, For Intravenous or Intramuscular use, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540. NDC: 43598-666-25

by Dr. Reddy's Laboratories, Inc.

Reason: Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
Published: October 15, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Norgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg, 3 Units, 3x28 tablets blister cards per carton, Rx only, Manufactured for AvKARE, Pulaski, TN 38478. Carton NDC: 42291-565-84; Blister NDC: 42291-565-28

by AvKARE

Reason: Failed Content Uniformity Specifications
Published: October 15, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-450-15.

by ACCORD HEALTHCARE, INC.

Reason: Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.
Published: October 15, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

AFCO, Hand Sanitizer (Isopropyl Alcohol-Based, Product 5515), Manufactured by: AFCO, 550 Development Avenue, Chambersburg, PA 17201, Toll Free: 800-345-1329, Package Configuration: a) 4x1 Gallon Case, 5 Gallon Pail, 55 Gallon Drum.

by Acuity Specialty Products, Inc.

Reason: cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.
Published: October 15, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Wyandotte, Sanifect E3, Hand Sanitizer (Ethanol-Based, Product 5511), Ethyl Alcohol 60.1%, Manufacture By: AFCO, 550 Development Avenue, Chambersburg, PA 17210, Toll Free: 800-345-1329, Package Configurations: a) 6x1000mL Case, b) 4x1 Gallon Case, c) 5 Gallon Pail, d) 55 Gallon Drum.

by Acuity Specialty Products, Inc.

Reason: cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.
Published: October 15, 2025
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Bevacizumab 1.75 mg/0.07 mL - 0.25 mL syringe, Intravitreal, 0.07 mL Total Volume, Rx Only, Hospital/Office Use Only, Refrigerate, RC Outsourcing LLC, Lowellville, OH 44436.

by RC Outsourcing, LLC

Reason: Lack of assurance of sterility.
Published: October 15, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-1.

by Apotex Corp.

Reason: Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Published: October 8, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1 (5 mL), NDC 60505-0589-2 (10 mL).

by Apotex Corp.

Reason: Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Published: October 8, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x10 unit dose cards), Rx Only, American Health Packaging, Columbus, OH 43217. Carton NDC 60687-594-21; (Individual Dose NDC: 60687-594-11)

by Amerisource Health Services LLC

Reason: Failed Dissolution Specifications.
Published: October 8, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06.

by Zydus Pharmaceuticals (USA) Inc

Reason: Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Published: October 8, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06.

by Zydus Pharmaceuticals (USA) Inc

Reason: Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Published: October 8, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass III

READYPREP PVP, Povidone-Iodine 10% Solution, Topical Antiseptic, Not Sterile, 1 Gallon (3.78 L) per bottle, Manufactured in USA by Medline Industries, LP., Three Lakes Drive, Northfield, IL 60093, NDC 53329-939-25

by Medline Industries, LP

Reason: Subpotent drug
Published: October 1, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass III

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 30 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-034-01

by Granules Pharmaceuticals Inc.

Reason: Failed Impurities/Degradation Specifications:
Published: October 1, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass III

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 20 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-032-01

by Granules Pharmaceuticals Inc.

Reason: Failed Impurities/Degradation Specifications:
Published: October 1, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass III

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 15 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-031-01

by Granules Pharmaceuticals Inc.

Reason: Failed Impurities/Degradation Specifications:
Published: October 1, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass III

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 10 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-030-01

by Granules Pharmaceuticals Inc.

Reason: Failed Impurities/Degradation Specifications:
Published: October 1, 2025
Distribution: Nationwide

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Data last updated: September 7, 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.