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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: AS ×
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Recalls announced by month (Year to date)

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Source: FDA and USDA public dataLast updated September 18, 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 I

Ceftriaxone for Injection USP, 1 g, packaged in a) one Single Use Vial (NDC 68180-633-01) and b) 10 Single Use Vials per box (NDC 68180-633-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.

by Lupin Pharmaceuticals Inc.

Reason: Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Published: January 16, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass I

Ceftriaxone for Injection USP, 500 mg, packaged in a) one Single Use Vial (NDC 68180-622-01) and b) 10 Single Use Vials per box (NDC 68180-622-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.

by Lupin Pharmaceuticals Inc.

Reason: Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Published: January 16, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass I

Ceftriaxone for Injection USP, 250 mg, packaged in a) one Single Use Vial (NDC 68180-611-01) and b) 10 Single Use Vials per box (NDC 68180-611-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.

by Lupin Pharmaceuticals Inc.

Reason: Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Published: January 16, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Cidofovir Injection 375mg/5mL (75mg/mL) vial injection. 5 mL vials, Rx only, Mfd by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, India Mfg. for : Heritage Pharmaceuticals Inc. NDC 23155-0216-31

by Heritage Pharmaceuticals, Inc.

Reason: Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle
Published: January 16, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag container bag, Rx only; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code 5B9766, NDC 0941-0424-52.

by Baxter Healthcare Corporation

Reason: Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing.
Published: January 16, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Nitrofurantoin Oral Suspension, USP, 25mg/5mL, 230 mL bottle, Rx only, Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873; Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, NDC 43386-450-11.

by LUPIN SOMERSET

Reason: Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.
Published: January 9, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Absorica (Isotretinoin) Capsules 30 mg USP, 30 capsules (3x10 Prescription Packs) Rx only, Manufactured by: Galephar Pharmaceutical Research Inc. Humacao, PR 00792, Distributed by: Sun Pharmaceutical Industries Inc. Cranbury, NJ 08512, UPC 310631117313, NDC 10631-117-31 (carton) NDC10631-117-69 (prescription pack)

by Sun Pharmaceutical Industries, Inc.

Reason: Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.
Published: December 26, 2018
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Nevirapine Extended Release Tablets, 400 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd. Verna Goa, India, Manufactured for: Cipla USA Inc. 9100 S Dadeland Blvd., Suite 1500 Miami, FL 33156, NDC 69097-403-02

by Cipla Limited

Reason: Failed Dissolution Specifications.
Published: December 26, 2018
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass I

Lubrisine eye drops (polyethylene glycol 400 0.4% and Propylene glycol 0.3%), 30 ML bottle, Manufactured and Distributed by: Results RNA, LLC, 1272 S 1380 W., Orem, UT 84058, UPC 7 9238230723 4

by Results RNA, LLC

Reason: Lack of Sterility Assurance and Incorrect/Undeclared excipient: Product was found to contain undeclared colloidal silver
Published: December 26, 2018
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Aprepitant Capsules, USP 40 mg, 1 capsule Unit Blister Pack, Rx Only, Manufactured in India for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430. UPC 368462583401. NDC 68462-583-40

by Glenmark Pharmaceuticals Inc., USA

Reason: Shortfill: Aprepitant capsules 40 mg is being recalled due to customer reports of missing capsule in the blister pack.
Published: December 26, 2018
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 unit dose cups (10x5ml unit dose cups per tray, 5 trays per case) NDC 66689-037-50; b) 100 unit dose cups (10x5ml unit dose cups per tray, 10 trays per case) NDC 66689-037-99. Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771

by VistaPharm, Inc.

Reason: Failed Impurities/Degradation Specifications:Out of specification for impurities.
Published: December 26, 2018
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Levoxyl (levothyroxine sodium tablets, USP) tablets 112 mcg, 100-count bottle, Rx Only,Distributed by Pfizer Inc. New York, NY 10017, NDC 60793-855-01

by Pfizer Inc.

Reason: Superpotent Drug.
Published: December 26, 2018
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Monsel's (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with applicators per box, Rx only, Gordon Laboratories, Upper Darby, PA 19082, NDC 10481-0112-8.

by Gordon Laboratories

Reason: Superpotent Drug: contains higher levels of Iron than labeled.
Published: December 26, 2018
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 39338 3.

by Tris Pharma Inc.

Reason: Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Published: December 26, 2018
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye-Free Non-Staining Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by Family Dollar Services, Inc., 10301 Monroe Road, Matthews, NC 28105, NDC 55319-250-23, UPC 0 32251 03374 2.

by Tris Pharma Inc.

Reason: Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Published: December 26, 2018
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-125-23, UPC 0 78742 02016 7.

by Tris Pharma Inc.

Reason: Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Published: December 26, 2018
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Fentanyl Citrate 2 mcg per mL (200 mcg per 100 mL) and Ropivacaine HCl 0.2% in Sodium Chloride 0.9%, Injection, 100 mL total volume in a 150 mL Intravia Bag, Rx Only,PharMEDium Services, LLC. 913 N. Davis Ave. Cleveland, MS 38732. NDC 61553-148-48

by PharMEDium Services, LLC

Reason: Sub-potent
Published: December 26, 2018
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Fentanyl Citrate 2 mcg per mL (100 mcg per 50 mL) and Ropivacaine HCl 0.1% in Sodium Chloride 0.9%, Injection, 50 mL total volume in a 60 mL BD Syringe, Rx Only, PharMEDium Services, LLC. 913 N. Davis Ave. Cleveland, MS 38732 NDC 61553-644-75.

by PharMEDium Services, LLC

Reason: Sub-potent
Published: December 26, 2018
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Estradiol Tablets, USP, 2 mg, 100-count bottle, Rx Only, Distributed by: Epic Pharma, LLC Laurelton, NY 11413, NDC 42806-089-01

by Epic Pharma, LLC

Reason: Presence of foreign tablet/capsule: A single foreign tablet was found in pharmacy dispensed bottle of 30 Estradiol 2 mg tablets.
Published: December 26, 2018
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/320 mg/25 mg, (a) 30-count bottles (NDC 0093-7809-56) & 90-count bottles (NDC 0093-7809-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.

by Teva Pharmaceuticals USA

Reason: CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Published: December 19, 2018
Distribution: Nationwide

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Data last updated: September 18, 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.