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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Drug Recall Ongoing Historical recordClass II

Testosterone Regular Release 50 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0401-01

by FARMAKEIO OUTSOURCING LLC

Reason: CGMP Deviations: Potential presence of metal particulate matter
Recall initiated: October 14, 2025
Reported by FDA: November 5, 2025
Distribution: Nationwide in the USA and Antigua

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Drug Recall Ongoing Historical recordClass II

Testosterone 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0381-01

by FARMAKEIO OUTSOURCING LLC

Reason: CGMP Deviations: Potential presence of metal particulate matter
Recall initiated: October 14, 2025
Reported by FDA: November 5, 2025
Distribution: Nationwide in the USA and Antigua

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Drug Recall Ongoing Historical recordClass II

Testosterone 87.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0386-01

by FARMAKEIO OUTSOURCING LLC

Reason: CGMP Deviations: Potential presence of metal particulate matter
Recall initiated: October 14, 2025
Reported by FDA: November 5, 2025
Distribution: Nationwide in the USA and Antigua

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Drug Recall Ongoing Historical recordClass II

Testosterone 62.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0383-01

by FARMAKEIO OUTSOURCING LLC

Reason: CGMP Deviations: Potential presence of metal particulate matter
Recall initiated: October 14, 2025
Reported by FDA: November 5, 2025
Distribution: Nationwide in the USA and Antigua

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Drug Recall Ongoing Historical recordClass II

Testosterone 50MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0387-01

by FARMAKEIO OUTSOURCING LLC

Reason: CGMP Deviations: Potential presence of metal particulate matter
Recall initiated: October 14, 2025
Reported by FDA: November 5, 2025
Distribution: Nationwide in the USA and Antigua

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Drug Recall Ongoing Historical recordClass II

Testosterone 25MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0389-01

by FARMAKEIO OUTSOURCING LLC

Reason: CGMP Deviations: Potential presence of metal particulate matter
Recall initiated: October 14, 2025
Reported by FDA: November 5, 2025
Distribution: Nationwide in the USA and Antigua

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Drug Recall Ongoing Historical recordClass II

Sting Relief Swabs, First Aid Only, 10 Swabs per box, part number 19-001, Manufactured for: Acme United Corporation, 1 Waterview Dr. Shelton, CT, Made in the USA UPC 738743190015

by ACME UNITED CORPORATION

Reason: Product Mix-up
Recall initiated: September 23, 2025
Reported by FDA: November 5, 2025
Distribution: USA Nationwide

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Drug Recall Ongoing Historical recordClass II

TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division, Fort Washington, PA 19034, NDC: 50580-378-04.

by Kenvue Brands LLC

Reason: Defective Container
Recall initiated: October 21, 2025
Reported by FDA: November 5, 2025
Distribution: U.S. Nationwide - CO, IL, OH and IN.

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Drug Recall Ongoing Historical recordClass II

Tirzepatide Injection, 27 mg/3 mL (9 mg/mL), 3mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-209-03

by ProRx LLC

Reason: Lack of Assurance of Sterility
Recall initiated: October 15, 2025
Reported by FDA: November 5, 2025
Distribution: TX and UT

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Drug Recall Ongoing Historical recordClass II

Semaglutide Injection, 5 mg/2 mL (2.5 mg/mL), 2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-02

by ProRx LLC

Reason: Lack of Assurance of Sterility
Recall initiated: October 15, 2025
Reported by FDA: November 5, 2025
Distribution: TX and UT

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Drug Recall Ongoing Historical recordClass II

Semaglutide Injection, 2.5mg/1mL (2.5 mg/mL), 1mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-06

by ProRx LLC

Reason: Lack of Assurance of Sterility
Recall initiated: October 15, 2025
Reported by FDA: November 5, 2025
Distribution: TX and UT

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Drug Recall Ongoing Historical recordClass II

Semaglutide Injection, 8mg/3.2mL (2.5 mg/mL), 3.2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-09

by ProRx LLC

Reason: Lack of Assurance of Sterility
Recall initiated: October 15, 2025
Reported by FDA: November 5, 2025
Distribution: TX and UT

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Drug Recall Ongoing Historical recordClass II

Semaglutide Injection, 6mg/2.4mL (2.5 mg/mL), 2.4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-08

by ProRx LLC

Reason: Lack of Assurance of Sterility
Recall initiated: October 15, 2025
Reported by FDA: November 5, 2025
Distribution: TX and UT

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Drug Recall Ongoing Historical recordClass II

Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-04

by ProRx LLC

Reason: Lack of Assurance of Sterility
Recall initiated: October 15, 2025
Reported by FDA: November 5, 2025
Distribution: TX and UT

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Drug Recall Ongoing Historical recordClass II

Semaglutide Injection, 12.5/5mL (2.5 mg/mL), 5mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-09

by ProRx LLC

Reason: Lack of Assurance of Sterility
Recall initiated: October 15, 2025
Reported by FDA: November 5, 2025
Distribution: TX and UT

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Drug Recall Ongoing Historical recordClass II

R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Tromethamine) in Sodium Chloride Solution, Total Volume: 50 mL syringe. INJECTION FOR PERIARTICULAR USE; Not for IV Use. THIS IS A COMPOUNDED DRUG. QuVA Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, TX 77478. NDC 70092-1433-50

by QuVa Pharma, Inc.

Reason: Presence of Particulate Matter
Recall initiated: October 10, 2025
Reported by FDA: November 5, 2025
Distribution: U.S. Nationwide

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Drug Recall Ongoing Historical recordClass II

Desipramine Hydrochloride Tablets, USP, 150 mg, 50 count bottle (NDC 23155-583-25), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.

by Heritage Pharmaceuticals Inc

Reason: CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Recall initiated: October 6, 2025
Reported by FDA: November 5, 2025
Distribution: U.S. Nationwide.

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Drug Recall Ongoing Historical recordClass II

Desipramine Hydrochloride Tablets, USP, 100 mg, 100 count bottle (NDC 23155-582-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.

by Heritage Pharmaceuticals Inc

Reason: CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Recall initiated: October 6, 2025
Reported by FDA: November 5, 2025
Distribution: U.S. Nationwide.

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Drug Recall Ongoing Historical recordClass II

Desipramine Hydrochloride Tablets, USP, 50 mg, 100 count bottle (NDC 23155-580-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.

by Heritage Pharmaceuticals Inc

Reason: CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Recall initiated: October 6, 2025
Reported by FDA: November 5, 2025
Distribution: U.S. Nationwide.

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Drug Recall Ongoing Historical recordClass II

Desipramine Hydrochloride Tablets, USP, 25 mg, 100 count bottle (NDC 23155-579-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.

by Heritage Pharmaceuticals Inc

Reason: CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Recall initiated: October 6, 2025
Reported by FDA: November 5, 2025
Distribution: U.S. Nationwide.

View recall →

Data last updated: September 6, 2026 ET

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.