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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 641–660 of 1,000 recalls

Class IIOngoing

Prazosin Hydrochloride, Capsules, USP, 1 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-996-01. Individual unit dose: NDC 68084-996-11

Amerisource Health Services LLC

Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit

October 16, 2025 · DrugView details →

Class IIOngoing

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

ProRx LLC

Lack of Assurance of Sterility

October 15, 2025 · DrugView details →

Class IIOngoing

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

ProRx LLC

Lack of Assurance of Sterility

October 15, 2025 · DrugView details →

Class IIOngoing

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

ProRx LLC

Lack of Assurance of Sterility

October 15, 2025 · DrugView details →

Class IIOngoing

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

ProRx LLC

Lack of Assurance of Sterility

October 15, 2025 · DrugView details →

Class IIOngoing

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

ProRx LLC

Lack of Assurance of Sterility

October 15, 2025 · DrugView details →

Class IIOngoing

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

ProRx LLC

Lack of Assurance of Sterility

October 15, 2025 · DrugView details →

Class IIOngoing

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

ProRx LLC

Lack of Assurance of Sterility

October 15, 2025 · DrugView details →

Class IIOngoing

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

FARMAKEIO OUTSOURCING LLC

CGMP Deviations: Potential presence of metal particulate matter

October 14, 2025 · DrugView details →

Class IIOngoing

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

FARMAKEIO OUTSOURCING LLC

CGMP Deviations: Potential presence of metal particulate matter

October 14, 2025 · DrugView details →

Class IIOngoing

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

FARMAKEIO OUTSOURCING LLC

CGMP Deviations: Potential presence of metal particulate matter

October 14, 2025 · DrugView details →

Class IIOngoing

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

FARMAKEIO OUTSOURCING LLC

CGMP Deviations: Potential presence of metal particulate matter

October 14, 2025 · DrugView details →

Class IIOngoing

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

FARMAKEIO OUTSOURCING LLC

CGMP Deviations: Potential presence of metal particulate matter

October 14, 2025 · DrugView details →

Class IIOngoing

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

FARMAKEIO OUTSOURCING LLC

CGMP Deviations: Potential presence of metal particulate matter

October 14, 2025 · DrugView details →

Class IIOngoing

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

FARMAKEIO OUTSOURCING LLC

CGMP Deviations: Potential presence of metal particulate matter

October 14, 2025 · DrugView details →

Class IIOngoing

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

FARMAKEIO OUTSOURCING LLC

CGMP Deviations: Potential presence of metal particulate matter

October 14, 2025 · DrugView details →

Class IIOngoing

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

FARMAKEIO OUTSOURCING LLC

CGMP Deviations: Potential presence of metal particulate matter

October 14, 2025 · DrugView details →

Class IIOngoing

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

FARMAKEIO OUTSOURCING LLC

CGMP Deviations: Potential presence of metal particulate matter

October 14, 2025 · DrugView details →

Class IIOngoing

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

FARMAKEIO OUTSOURCING LLC

CGMP Deviations: Potential presence of metal particulate matter

October 14, 2025 · DrugView details →

Class IIOngoing

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

FARMAKEIO OUTSOURCING LLC

CGMP Deviations: Potential presence of metal particulate matter

October 14, 2025 · DrugView details →

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