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Recall totals

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

37,115

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/so-delicious-dairy-freer-issues-voluntary-recall-salted-caramel-cluster-non-dairy-frozen-dessertPublished September 15, 2026

Most affected stateHawaii 200 recalls mention this state

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

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Source: FDA and USDA public dataLast updated September 16, 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

Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per carton (10 capsules x 10 blister cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC Carton: 68084-446-01; NDC Blister Card: 68084- 446-11

by American Health Packaging

Reason: Failed Dissolution Specifications
Published: January 27, 2021
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Oxycodone Hydrochloride Oral Solution, USP 5 mg/5mL unit dose cups, Rx Only, Genus Lifesciences Inc. NDC 64950-354-05 Case NDC: 64950-354-450(40 unit dose cups) Case NDC 64950-354-55 (50 unit dose cups)

by Genus Lifesciences Inc.

Reason: Presence of Foreign Substance: Particulate matter was found in multiple lots of product.
Published: January 20, 2021
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Chlorhexidine Gluconate Oral Rinse USP 0.12%, packaged in a) 15 mL x 30 Unit Dose Cups (30-pack case) NDC 68094-028-61, b) 15 mL x 100 Unit Dose Cups (100-pack case) NDC 68094-028-62, Rx only, Precision Dose, Inc., South Beloit, IL 61080.

by Precision Dose Inc.

Reason: cGMP deviations: The firm was notified of the manufacturer's expanded recall.
Published: January 20, 2021
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 tablets per bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120, NDC: 29033-056-01

by Nostrum Laboratories Inc

Reason: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Published: January 20, 2021
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Methotrexate, USP Sterile Solution for Injection, Preservative Free 125mg/5ml (25mg/ml), 5 mL per syringe, Rx Only, SYRINGE FOR IM INJECTION, Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178, Barcode 0544650505

by Edge Pharma, LLC

Reason: Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
Published: January 20, 2021
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets, Rx Only, Manufactured for: KVK-Tech, Inc., Newtown, PA 18940 USA, NDC 10702-344-01

by KVK-Tech, Inc.

Reason: Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity during the 12-month long term stability testing for Batch# 15892A
Published: January 20, 2021
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Succinylcholine Chloride PF Inj. 200 mg/10 mL, 10 mL single use syringes, Rx only, US Compounding, 1270 Don's Lane, Conway, AR 72032

by US Compounding Inc

Reason: Labeling: Incorrect or Missing lot and/or expiration date: The lot number and BUD were printed in the incorrect position on the product label making it illegible.
Published: January 20, 2021
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473mL) NDC 52376-021-02; b) 4 fl oz (118 mL) NDC 052376-021-04, Sunstar Americas, Inc., Schaumburg, IL

by Sunstar Americas, Inc.

Reason: cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary conditions
Published: January 20, 2021
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Levetiracetam Oral Solution, 100 mg/mL, 16 fl oz (473 mL) bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-241-16

by Akorn, Inc.

Reason: Defective container: Customer complaints for oral solution leaking from bottles.
Published: January 20, 2021
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Ketamine 50 mg/5mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004043009

by SCA Pharmaceuticals

Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Published: January 13, 2021
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

PHENYLephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9% (100 mcg/mL) Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081022

by SCA Pharmaceuticals

Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Published: January 13, 2021
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

HYDROmorphone HCl 10mg/50mL in 0.9% Sodium Chloride Injection, CII, Rx Only, 50 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004030022

by SCA Pharmaceuticals

Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Published: January 13, 2021
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

fentaNYL 100 mcg/2mL Injection for IV or IM Use, 2 mL Single Dose Syringe, CII, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 barcode 70004020006

by SCA Pharmaceuticals

Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Published: January 13, 2021
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

ePHEDrine 25 mg/5 mL in 0.9% Sodium Chloride Injection, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals 8521 Knoedl Ct., Little Rock, AR, 72205, barcode 70004060409

by SCA Pharmaceuticals

Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Published: January 13, 2021
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

SUCcinylcholine Chloride 100 mg/5mL, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., WIndsor, CT, 06095, barcode 70004090809

by SCA Pharmaceuticals

Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Published: January 13, 2021
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Rocuronium Br 50 mg/5mL (10 mg/mL), a) 5 mL Single Dose Syringe Red Label(barcode 7000485009) Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 and b) 5 mL Single Dose Syringe White Label (barcode 70004085028), Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205

by SCA Pharmaceuticals

Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Published: January 13, 2021
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

PHENYLephrine HCl 500 mcg/5mL in 0.9% Sodium Chloride (100 mcg/mL), Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081011

by SCA Pharmaceuticals

Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Published: January 13, 2021
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Morphine Sulfate 30 mg/30 mL in 0.9% Sodium Chloride (1mg/ml), CII, Rx Only, 30 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010016

by SCA Pharmaceuticals

Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Published: January 13, 2021
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

SUCccinylcholine Chloride 200 mg/10 mL, (20 mg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004090812

by SCA Pharmaceuticals

Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Published: January 13, 2021
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Sodium Citrate 4% 3 mL Anticoagulation Solution (40mg/mL), Rx only, 3 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004090025

by SCA Pharmaceuticals

Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Published: January 13, 2021
Distribution: Nationwide

View recall →

Data last updated: September 16, 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.