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Recall totals

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

37,063

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/evergreen-fresh-sprouts-llc-recalls-broccoli-sprouts-because-possible-health-riskPublished September 10, 2026

Most affected stateHawaii 200 recalls mention this state

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

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Source: FDA and USDA public dataLast updated September 11, 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

CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Cherry Flavor, 10 fl. oz bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, NDC 51316-881-10.

by Pharma Nobis LLC

Reason: Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria
Published: May 22, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose Vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, Made in India. NDC: 25021-820-10

by Sagent Pharmaceuticals

Reason: Presence of Particulate Matter: Potential for black particulates in the drug product.
Published: May 22, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-050-44

by MACLEODS PHARMA USA, INC

Reason: Presence of foreign substance: plastic-like substance.
Published: May 22, 2024
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046, India, NDC 68180-722-04

by Lupin Pharmaceuticals Inc.

Reason: Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Published: May 22, 2024
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046, India, NDC 68180-723-04

by Lupin Pharmaceuticals Inc.

Reason: Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Published: May 22, 2024
Distribution: Nationwide

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FDA Recall Completed Historical recordClass II

Gordofilm Wart Remover (salicylic acid 16.7% USP) packaged in 15 cc glass jars, Gordon Laboratories, Upper Darby PA 19082, NDC 10481-3009-01

by Dercher Enterprises, Inc., DBA Gordon Laboratories

Reason: cGMP Deviations
Published: May 22, 2024
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass III

East West Tea Company, LLC

Product: Organic Yogi Echinacea Immune Support, Caffeine Herbal Suppl…
Reason: Organic Yogi Echinacea Immune Support product is recalled because pesticide residues were detected above action levels.
Published: May 22, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Amphotericin B Liposome for Injection, 50mg vials, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Medicare Limited, Baska Ujeti Road, Ujeti Halol-389350, Gujarat, India. NDC 62756-233-01

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason: Out of specification for assay
Published: May 15, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 13107-283-01, b) 500 tablets per bottle, NDC 13107-283-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.

by Aurobindo Pharma USA Inc.

Reason: Discoloration: Dotted and yellow spots on tablets
Published: May 15, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per bottle, NDC 13107-282-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.

by Aurobindo Pharma USA Inc.

Reason: Discoloration: Dotted and yellow spots on tablets
Published: May 15, 2024
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle, Manufactured for Acela Pharmaceuticals, LLC Alphareta, GA 30005, NDC 42192-136-06

by Acella Pharmaceuticals, LLC

Reason: Subpotent drug
Published: May 15, 2024
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3824-00; (b) 90-count blister pack, NDC 70518-3824-02; (a) 180-count blister pack, NDC 70518-3824-03; RX ONLY, MFG: Advagen Pharma Limited, Plainsboro. NJ 08536, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, 724.465.8762

by RemedyRePack Inc.

Reason: Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count tramadol
Published: May 15, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distributed by: Advagen Pharma Limited, 666 Plainsboro Road Suite 605, Plainsboro, NJ, 08536, USA, Manufactured by: Rubicon Research, Private Limited, Ambernath, Dist. Thane, 421506 India NDC 72888-080-00

by Rubicon Research Private Limited

Reason: Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
Published: May 15, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass I

Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-477-30.

by Dr. Reddy's Laboratories, Inc.

Reason: Sub-potent Drug; powder discoloration associated with decreased potency
Published: May 15, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass I

Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-097-30.

by Dr. Reddy's Laboratories, Inc.

Reason: Sub-potent Drug; powder discoloration associated with decreased potency
Published: May 15, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922, NDC: 51991-748-90.

by Breckenridge Pharmaceutical, Inc

Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Published: May 15, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 20 mg, , 500-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922, NDC 51991-746-05.

by Breckenridge Pharmaceutical, Inc

Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Published: May 15, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles (NDC 51991-747-90), (b) 1000-count bottles (NDC 51991-747-10), Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.

by Breckenridge Pharmaceutical, Inc

Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Published: May 15, 2024
Distribution: Nationwide

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FDA Recall Completed Historical recordClass III

Valacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-4275-77

by Viatris Inc

Reason: Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.
Published: May 8, 2024
Distribution: Nationwide

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FDA Recall Completed Historical recordClass III

Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: Hikma Injectables USA Inc. 2 Esterbrook Lane, Cherry Hill, NJ 08003, Distributed by: Hikma Injectables USA Inc. 36 Stults Road, Dayton, NJ 08810, NDC 63037-100-05

by Hikma Injectables USA Inc

Reason: Labeling: Wrong Barcode
Published: May 8, 2024
Distribution: Nationwide

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Data last updated: September 11, 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.