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

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Source: FDA and USDA public dataLast updated September 17, 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

Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, packaged in a 8 fl oz (237 mL) bottle, Rx only, Manufactured By Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053. NDC 60432-212-08

by Morton Grove Pharmaceuticals, Inc.

Reason: Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14
Published: October 16, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Sandoz Ranitidine Hydrochloride Capsules 300mg 30 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Product of India NDC 0781-2865-31

by Sandoz, Inc

Reason: CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
Published: October 16, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Sandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Product of India NDC 0781-2855-05

by Sandoz, Inc

Reason: CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
Published: October 16, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ Product of India NDC 0781-2855-60

by Sandoz, Inc

Reason: CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
Published: October 16, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Major Infants' Gas Relief Drops, Simethicone Oral Suspension USP, 1 FL OZ (30 mL) bottle, Distributed by: Major Pharmaceuticals 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 USA. NDC 0904-5894-30

by GCP Laboratories Inc

Reason: Microbial Contamination of Non-Sterile Product.
Published: October 16, 2019
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass II

Abbott Laboratories

Product: Abbott Calcilo XD, Low-calcium Vitamin D-Free Infant formula…
Reason: Off color and odor. Compromised can seam due to product (powder) in the seam, this poor seal potentially allowed air into the container.
Published: October 16, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd. by: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-201-15.

by Akorn, Inc.

Reason: Lack of Assurance of Sterility: Out of specification results for container closure test which cannot guarantee the sterility of the product.
Published: October 9, 2019
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-118-90

by Torrent Pharma Inc.

Reason: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.
Published: October 9, 2019
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-116-90

by Torrent Pharma Inc.

Reason: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.
Published: October 9, 2019
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Losartan Potassium Tablets, USP 100 mg, [90 or 1000] tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC 90 tablets: 13668-115-90; NDC 1000 tablets: 13668-115-10

by Torrent Pharma Inc.

Reason: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.
Published: October 9, 2019
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Losartan Potassium Tablets, USP 50mg, 1000 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-409-10

by Torrent Pharma Inc.

Reason: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.
Published: October 9, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial. Each Carton Contains: 1) One vial of 380 mg of Vivitrol, 2) One vial containing 4 mL of diluent, 3) One 5-mL prepackaged syringe, 4) One 20-gauge 1-inch needle, 5) Two 20-gauge 1.5-inch safety needles, 6) Two 20-gauge 2-inch safety needles. Rx Only. Manufactured and marketed by: Alkermes, Inc. Kit NDC: 65757-300-01

by Alkermes, Inc.

Reason: Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch needle cardboard sleeve labelled as administration needles. The product vial is not impacted.
Published: October 9, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Isoproterenol HCL (PF) in D5W, 200 mcg / 50 mL (4 mcg/mL), 50 mL IV Bag, Single Dose Only, Contains Sulfites, For Slow IV use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677610

by KRS Global Biotechnology, Inc

Reason: Lack of Assurance of Sterility
Published: October 9, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

L-Asparaginase Lyophilized, 10,000 International Units/Vial, For IV / IM / SC Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674499

by KRS Global Biotechnology, Inc

Reason: Lack of Assurance of Sterility
Published: October 9, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 10% (100 mg/mL) / Tropicamide 1% (10 mg/mL) / Ketorolac Tromethamine 0.5% (5 mg/mL), Sterile Ophthalmic Topical Solution, 5 mL Fill in a 7 mL Droptainer,Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676223

by KRS Global Biotechnology, Inc

Reason: Lack of Assurance of Sterility
Published: October 9, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Vitamin B1/B2/B3/B6/HYDROXOCOBALAMIN 66/1.33/66/66/0.66 mg/mL (PF), For IV Use, 3 mL fill in a 5 mL Single Dose Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678335

by KRS Global Biotechnology, Inc

Reason: Lack of Assurance of Sterility
Published: October 9, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Vitamin 9A/B Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678339

by KRS Global Biotechnology, Inc

Reason: Lack of Assurance of Sterility
Published: October 9, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Vitamin 9 Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674147

by KRS Global Biotechnology, Inc

Reason: Lack of Assurance of Sterility
Published: October 9, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Vitamin 5 B, 30 mL Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674253

by KRS Global Biotechnology, Inc

Reason: Lack of Assurance of Sterility
Published: October 9, 2019
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Vitamin 10 D Lyophilized, Vial For IM/Slow IV Infusion Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678341

by KRS Global Biotechnology, Inc

Reason: Lack of Assurance of Sterility
Published: October 9, 2019
Distribution: Nationwide

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Data last updated: September 17, 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.