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Recall totals

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

37,449
Total recall recordsAll FDA and USDA recalls in Public Health Trace
9,872
Class I recallsReasonable probability of serious health consequences
24,509
Class II recallsTemporary or medically reversible health consequences
2,932
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 2,096 recalls
Most affected stateHawaii 200 recalls mention this state

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Download matching recalls as CSV

CSV exports include up to 5,000 matching rows (applying your current filters), not the full dataset if it's larger.

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Recalls announced by month (Year to date)

A chart of recalls grouped by month.

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Source: FDA and USDA public dataLast updated

Summary (Year to date)

  • 1,956 recalls have been announced year to date.
  • Oct 2026 was 4% higher than the previous complete period (Sep 2026: 209).
  • The highest complete period was Jun 2026 (300).
  • Nov 2026 is incomplete and not included in the figures above.
  • Complete data
  • Incomplete
Recalls by class

A bar chart of the total number of recalls in this dataset by recall class.

Recalls by class
ClassRecalls
Class II24,509
Class I9,872
Class III2,932
Not Yet Classified2
Download CSV
Recalls by class
ClassRecalls
Class II24,509
Class I9,872
Class III2,932
Not Yet Classified2

Showing 10,801–10,820 of 21,307 recalls

FDA Recall TerminatedTerminated: September 30, 2020Historical recordClass II

Pramipexole Dihydrochloride Tablets, 0.25 mg, 100 Tablets (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-440-11; NDC Carton: 68084-440-01

by American Health Packaging

Reason
GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Published
July 3, 2019
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: May 24, 2023Historical recordClass II

Diphenhydramine HCL Liquid, 12.5 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0123-03.

by H J Harkins Company Inc dba Pharma Pac

Reason
Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Published
July 3, 2019
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: May 24, 2023Historical recordClass II

Acetaminophen Children's Liquid, 160 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0309-04

by H J Harkins Company Inc dba Pharma Pac

Reason
Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Published
July 3, 2019
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: October 26, 2021Historical recordClass II

Riboflavin 5-Phosphate Sodium Ophthalmic Solution, 19.05mg/3mL (6.35 mg/mL), 3 mL Dropper Bottle, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-106-61, barcode 1 69623 10661 9.

by Premier Pharmacy Labs Inc

Reason
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Published
July 3, 2019
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: October 26, 2021Historical recordClass II

Phenylephrine HCL PF INJ in 0.9% Sodium Chloride, 1000mcg/10mL (100mgc/mL), *Contains Sulfites*, 10mL Single-Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-236-16, barcode 8 69623 23616 2.

by Premier Pharmacy Labs Inc

Reason
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Published
July 3, 2019
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: October 26, 2021Historical recordClass II

Orphenadrine Citrate Sterile Injectable Solution *Contains Sulfites*, 30mg/mL, 1mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-104-10, barcode 7 69623 10410 5.

by Premier Pharmacy Labs Inc

Reason
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Published
July 3, 2019
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: October 26, 2021Historical recordClass II

Naloxone HCL Preserved INJ, 500mg/50mL (10mg/mL), 50mL Sterile MDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-235-39, barcode 6 69623 23539 0.

by Premier Pharmacy Labs Inc

Reason
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Published
July 3, 2019
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: October 26, 2021Historical recordClass II

Mitomycin Preservative Free Irrigation, 40mg/10mL (4mg/mL), 10mL SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-160-35, barcode 5 69623 16035 0.

by Premier Pharmacy Labs Inc

Reason
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Published
July 3, 2019
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: October 26, 2021Historical recordClass II

Isoproterenol HCL in D5W (Sterile to Sterile), 200mcg/50mL (4mcg/mL), 50mL Sterile Single-Dose Bag, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-230-57, barcode 0 69623 23057 7.

by Premier Pharmacy Labs Inc

Reason
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Published
July 3, 2019
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: October 26, 2021Historical recordClass II

Dexamethasone Sodium Phosphate Preservative Free Sterile Solution for INJ, 24mg/mL, 1mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-252-10, barcode 0 69623 25210 4.

by Premier Pharmacy Labs Inc

Reason
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Published
July 3, 2019
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: September 30, 2020Historical recordClass II

Pramipexole Dihydrochloride Tablets, 0.125 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-793-95; NDC Carton: 68084-793-25

by American Health Packaging

Reason
GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Published
July 3, 2019
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: October 26, 2021Historical recordClass II

SUCCINYLcholine Chloride, 200mg/10mL (20mg/mL), 10mL Sterile Single Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-239-16, barcode 9 69623 23916 0.

by Premier Pharmacy Labs Inc

Reason
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Published
July 3, 2019
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: October 26, 2021Historical recordClass II

SUCCINYLcholine Chloride, 100mg/5mL (20mg/mL), 5mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-239-15, barcode 0 69623 23915 0.

by Premier Pharmacy Labs Inc

Reason
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Published
July 3, 2019
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: October 26, 2021Historical recordClass II

Sodium Bicarbonate INJ 8.4%, 50 mEq/50mL (84mg/mL) (1mEq/mL), 50mL Sterile SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-232-39, barcode 8 69623 23239 3.

by Premier Pharmacy Labs Inc

Reason
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Published
July 3, 2019
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: October 26, 2021Historical recordClass II

Neostigmine Methylsulfate, 5mg/5mL (1mg/mL), 5mL Single Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-234-15, barcode 5 69623 23415 0.

by Premier Pharmacy Labs Inc

Reason
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Published
July 3, 2019
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: October 26, 2021Historical recordClass II

Lidocaine 0.5%/Phenylephrine 0.75% P.F. INJ, 1mL Sterile SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-176-31, barcode 6 69623 17631 0.

by Premier Pharmacy Labs Inc

Reason
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Published
July 3, 2019
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: October 26, 2021Historical recordClass II

Isoproterenol HCL in D5W, 500mcg/50mL (10mcg/mL), 50mL Sterile Single-Dose Bag, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-107-57, barcode 3 69623 10757 3.

by Premier Pharmacy Labs Inc

Reason
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Published
July 3, 2019
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: October 26, 2021Historical recordClass II

Isoproterenol HCL in D5W (Non Sterile to Sterile), 200mcg/50mL (4mcg/mL), 50mL Sterile Single-Dose Bag, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-240-57, barcode 0 69623 24057 7.

by Premier Pharmacy Labs Inc

Reason
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Published
July 3, 2019
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: October 26, 2021Historical recordClass II

Droperidol Injectable Sterile Solution, 0.625mg/mL, 1mL in a 3mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-185-10, barcode 0 69623 18510 5.

by Premier Pharmacy Labs Inc

Reason
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Published
July 3, 2019
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: October 26, 2021Historical recordClass II

ChlorproMAZINE HCL INJ, 25mg/mL, *Contains Sulfites*, 1mL in a 5mL Sterile SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-122-28, barcode 7 69623 12228 4.

by Premier Pharmacy Labs Inc

Reason
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Published
July 3, 2019
Distribution
Nationwide

View recall →

Data last updated:

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.

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