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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 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

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

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 Terminated Historical 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 Terminated Historical 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 Terminated Historical 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 Terminated Historical 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 Terminated Historical 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

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FDA Recall Terminated Historical 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 Terminated Historical 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 Terminated Historical 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 Terminated Historical 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 Terminated Historical 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 Terminated Historical 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 Terminated Historical 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 Terminated Historical 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 Terminated Historical 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 →

FDA Recall Terminated Historical recordClass II

Brilliant Blue Ophthalmic PF INJ, 0.5mg/mL (0.05%), 1 mL SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-211-31, barcode 2 69623 21131 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 Terminated Historical recordClass II

Atropine Sulfate PF INJ, 0.8 mg/2 mL (0.4 mg/mL), 2mL Single Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-131-12, barcode 0 69623 13112 6.

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 Terminated Historical recordClass II

MethylPREDNISolone Tablets, USP 8 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-917-11

by Zydus Pharmaceuticals USA Inc

Reason: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Published: June 26, 2019
Distribution: Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Pramipexole Dihydrochloride Tablets 1.5 mg 90-count bottle, Rx only Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ NDC 68382-200-16

by Zydus Pharmaceuticals USA Inc

Reason: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Published: June 26, 2019
Distribution: Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

MethylPREDNISolone Tablets, USP 32 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-919-11

by Zydus Pharmaceuticals USA Inc

Reason: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Published: June 26, 2019
Distribution: Nationwide

View recall →

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.