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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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Showing 781–800 of 18,047 drug recalls

Drug Recall Ongoing Historical recordClass II

Testosterone / Triamcinolone Acetonide Pellet (200MG/40MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0364-01

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

View recall →

Drug Recall Ongoing Historical recordClass II

Testosterone / Triamcinolone Acetonide Pellet (100MG/20MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0367-01

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

View recall →

Drug Recall Ongoing Historical recordClass II

Testosterone / Triamcinolone Acetonide 87.5MG/17.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0382-01

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

View recall →

Drug Recall Ongoing Historical recordClass II

Testosterone / Triamcinolone Acetonide, 62.5MG/12.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0366-01

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

View recall →

Drug Recall Ongoing Historical recordClass II

Testosterone / Triamcinolone Acetonide 50MG/10MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0365-01

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

View recall →

Drug Recall Ongoing Historical recordClass II

Testosterone / Triamcinolone Acetonide Pellet (37.5MG/7.5MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0380-01

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

View recall →

Drug Recall Ongoing Historical recordClass II

Testosterone / Triamcinolone Acetonide 25MG/5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0379-01

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

View recall →

Drug Recall Ongoing Historical recordClass II

Testosterone / Triamcinolone Acetonide, 12.5MG/2.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0363-01

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

View recall →

Drug Recall Ongoing Historical recordClass II

Testosterone Regular Release 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0402-01

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

View recall →

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

View recall →

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

View recall →

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

View recall →

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

View recall →

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

View recall →

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

View recall →

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

View recall →

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.

View recall →

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

View recall →

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

View recall →

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

View recall →

Data last updated:

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.

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