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Recall totals

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

37,066

Total recall recordsAll FDA and USDA recalls in Public Health Trace

9,786

Class I recallsReasonable probability of serious health consequences

24,313

Class II recallsTemporary or medically reversible health consequences

2,876

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/whole-foods-market-issues-allergy-alert-undeclared-egg-cabricharme-cheesePublished September 11, 2026

Most affected stateHawaii 200 recalls mention this state

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

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Source: FDA and USDA public dataLast updated September 14, 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	24,313
Class I	9,786
Class III	2,876
Not Yet Classified	2

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Recalls by class
Class	Recalls
Class II	24,313
Class I	9,786
Class III	2,876
Not Yet Classified	2

FDA Recall Ongoing Historical recordClass II

Granisetron HCl Injection, USP, 1 mg/mL, packaged in a) 1mL and b) 4 mL vials, Rx Only, For Intravenous Use Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

by Akorn, Inc.

Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Published: June 7, 2023
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Gonak Hypromellose Ophthalmic Solution 25mg/mL, 15 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

by Akorn, Inc.

Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Published: June 7, 2023
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Fluticasone Propionate Nasal Spray, 50mcg, 16 g bottles, Manufactured by: HI-TECH PHARMACAL CO., INC., Amiy. ALL NDCs

by Akorn, Inc.

Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Published: June 7, 2023
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

DOCU LIQUID (docusate sodium, 50 mg/5 mL), packaged in 473mL bottles and b)10mL Unit Dose cups, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs

by Akorn, Inc.

Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Published: June 7, 2023
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

DetomiSed (detomidine hydrochloride) packaged in a) 5mL and b)20mL vials, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs

by Akorn, Inc.

Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Published: June 7, 2023
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Clobetasol Propionate Shampoo, 0.05%, 4oz (118 mL) bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs

by Akorn, Inc.

Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Published: June 7, 2023
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Cimetidine HCl Oral Solution 300mg/5mL, 237 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs

by Akorn, Inc.

Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Published: June 7, 2023
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Cetrorelix Acetate for Injection, 0.25 mg, , One carton contains one packaged tray which contains: 1 vial with lyophilized powder for reconstitution, 1 pre-filled syringe with diluent, 1 20-gauge needle, 1 27-gauge needle, Sterile - For subcutaneous use only, Rx Only, Manufactured by: GP Pharm S.A. Barcelona, Spain (ESP) -08777, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs

by Akorn, Inc.

Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Published: June 7, 2023
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Calcipotriene Topical Solution, 0.005% (Scalp Solution), 60 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs

by Akorn, Inc.

Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Published: June 7, 2023
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Albuterol Sulfate Syrup, 2mg (base), 16 fl oz (473 mL) per bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

by Akorn, Inc.

Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Published: June 7, 2023
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Acyclovir Oral Suspension, 200mg/5mL, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

by Akorn, Inc.

Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Published: June 7, 2023
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Acetic Acid Otic Solution, 15 mL per bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

by Akorn, Inc.

Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Published: June 7, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Compounded by: Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, Massachusetts 01801-1042 United States, NDC 71546-451-25

by New England Life Care, Inc. dba Advanced Compounding Solutions

Reason: Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride
Published: June 7, 2023
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Waltham, MA 02451, NDC # 49230-300-10

by Fresenius Medical Care Holdings, Inc.

Reason: Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.
Published: June 7, 2023
Distribution: Product was distributed to 32 clinics in…

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FDA Recall Ongoing Historical recordClass II

Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottle. Distributed by Ketomi LLC, 1215 Sarasota Center Blvd., Sarasota FL 34240.

by Denison Pharmaceuticals, LLC

Reason: CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Published: June 7, 2023
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Safe tussin DM, DAY TIME Cough Relief, (Dextromethorphan HBr, USP 10mg Guaifenesin, USP 100mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807.

by Denison Pharmaceuticals, LLC

Reason: CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Published: June 7, 2023
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Tropicamide Ophthalmic Solution, USP 0.1%, 15 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

by Akorn, Inc.

Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Published: June 7, 2023
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Ropivacaine Hydrochloride Injection USP, 0.2%, 200mg/100 mL (2 mg/mL), 100 mL Vial, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs

by Akorn, Inc.

Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Published: June 7, 2023
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Pilocarpine Hydrochloride Ophthalmic Solution, USP 2%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

by Akorn, Inc.

Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Published: June 7, 2023
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Olopatadine HCl Ophthalmic Solution, USP, 0.2%, 5mL bottles, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

by Akorn, Inc.

Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Published: June 7, 2023
Distribution: Nationwide

View recall →

Data last updated: September 14, 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.