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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: AS ×
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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

Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, 16 fl oz (473 mL) Rx Only, pai, Pharmaceutical Associates, Inc. Greenville, SC 29605. NDC 0121-0810-16

by Pharmaceutical Associates Inc

Reason: Subpotent: Out of specification for assay at the 12-month time point.
Published: February 5, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : Macleods Pharma USA, Inc. Plainsboro, NJ Manufactured by: Macleods Pharmaceuticals Ltd Baddi, Himachal Pradesh, India NDC 33342-111-10

by Macleods Pharma Usa Inc

Reason: Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
Published: February 5, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Walgreens Acne Cleansing Bar, Benzoyl Peroxide 10%, NET WT 4 oz (113 g), 1 bar per carton, Distributed By: Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015, NDC: 0363-0137-11

by Shandex Personal Care Manufacturing Inc.

Reason: Presence of Foreign Substance; Metal contaminant visible in product (screen wire from manufacturing).
Published: February 5, 2020
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass I

WHOLE FOODS MARKET

Product: 365 Everyday Value Dark Chocolate Caramel Sea Salt Sandwich…
Reason: Potential to contain undeclared milk and coconut.
Published: February 5, 2020
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass I

WHOLE FOODS MARKET

Product: 365 Everyday Value Dark Chocolate Peppermint Sandwich Cremes…
Reason: Potential to contain undeclared milk.
Published: February 5, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only, Mfd by: HIKMA FARMACEUTICA (PORTUGAL), SA; Dist by: WEST-WARD, Eatontown, NJ 07724, NDC 0143-9850-01.

by Hikma Pharmaceuticals USA Inc.

Reason: Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to reconstitute product with 16 mL rather than the correct volume of 8 mL of Bacteriostatic Water for Injection with Benzyl Alcohol.
Published: January 29, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Entropic Labs SARM RAD-140, 20mg Capsules, 30-count bottles, Entropic Labs UPC#: 651074545302

by Tuscano and Delucia Group (DBA Entropic Labs)

Reason: Marketed Without An Approved NDA/ANDA: product contains Selective Androgen Receptor Modulators (SARMs)
Published: January 29, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

NETSPOT, (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, For Intravenous Use Only, Rx Only, Manufactured for: Advanced Accelerator Applications USA, Inc. by Gipharma S.r.l. Strada Crescentino snc, 13040 Saluggia (Vc), Italy, NDC 69488-001-40.

by Advanced Accelerator Applications USA, Inc.

Reason: Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).
Published: January 29, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Ranitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 90-count bottles (NDC 70934-287-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131

by Denton Pharma, Inc.

Reason: CGMP Deviations: Presence of NDMA impurity detected in product.
Published: January 29, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Ranitidine Tablets, USP 150 mg , a). 4 count bottle (NDC 70934-017-04), b). 20-count bottle (NDC 70934-017-20), c). 24-count bottle (NDC 70934-017-24) d). 30-count bottle (NDC 70934-017-30) e). 90-count bottle (NDC 70934-017-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131.

by Denton Pharma, Inc.

Reason: CGMP Deviations: Presence of NDMA impurity detected in product.
Published: January 29, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass I

Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL Single Dose Vials (NDC 0641-6042-01), 25 vials/shelf-pack (NDC 0641-6042-25), For IV or IM Use Only, Rx only, Manufactured by: WEST-WARD Eatontown, NJ 07724 USA.

by Hikma Pharmaceuticals USA Inc.

Reason: Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
Published: January 22, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Lipoic Acid Injection (aka Alpha Lipoic Acid or Thioctic Acid), 1,200 mg/30 mL (40 mg/mL) Sterile 30 mL Multiple Dose Vial, Rx Only, McGuff Compounding Pharmacy Services, Inc., Santa Ana, CA 92704

by McGuff Compounding Pharmacy Services, Inc.

Reason: Presence of Particulate Matter: filmy/cloudy particulate observed in vial.
Published: January 22, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets, USP), 0.180 mg/0.025 mg; 0.215mg/0.025 mg and 0.250 mg/0.025 mg, Pack size - 3 x 28's wallets/carton, Rx Only, Distributed by Lupin Pharmaceuticals, Inc, Baltimore MD 21202, Manufactured by: Lupin Limited, Pithampur, (M.P.)- 454775, India. NDC 68180-837-13 (3x28 carton ) NDC 68180-837-11 (28 tablet wallet)

by Lupin Pharmaceuticals Inc.

Reason: CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.
Published: January 22, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For Topical Ophthalmic Use Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, Made in India, NDC 65862-840-03.

by AuroMedics Pharma LLC

Reason: Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.
Published: January 22, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

TRIMIX SUPER (A) 30MG/2MG/30MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800

by Assurance Infusion

Reason: Lack of sterility assurance.
Published: January 22, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

TRIMIX FORTE PLUS 30MG/4MG/40MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800

by Assurance Infusion

Reason: Lack of sterility assurance.
Published: January 22, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

TRIMIX FORTE 30MG/2MG/20MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800

by Assurance Infusion

Reason: Lack of sterility assurance.
Published: January 22, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

TRIMIX -A (UA) 30MG/1MG/5 MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800

by Assurance Infusion

Reason: Lack of sterility assurance.
Published: January 22, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

TRIMIX (UA) 30MG/1MG/20MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800

by Assurance Infusion

Reason: Lack of sterility assurance.
Published: January 22, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

TRIMIX 30MG/1MG/10MCG/ML INJ in 5 mL/10 mL vials Assurance Infusion (713) 533-8800

by Assurance Infusion

Reason: Lack of sterility assurance.
Published: January 22, 2020
Distribution: Nationwide

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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.