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Testosterone Cypionate

FDA recalls

12 rows

DateCompany and reasonClass
Apr 9, 2025Eugia US LLC
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.		Class II · Ongoing
Feb 14, 2023Azurity Pharmaceuticals, Inc.
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.		Class II · Terminated
Jun 20, 2022Sun Pharmaceutical Industries Inc
cGMP - Water leakage		Class II · Terminated
Jun 9, 2022Sun Pharmaceutical Industries Inc
Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion		Class II · Terminated
Jun 2, 2022Sun Pharmaceutical Industries Inc
CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery.		Class II · Terminated
Jun 2, 2022Sun Pharmaceutical Industries Inc
CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to manufacturing issues that could cause the product to be out of specification for impurities.		Class II · Terminated
Jan 10, 2021Sun Pharmaceutical Industries Inc
Incorrect Labeling: Incorrect lot number on secondary packaging		Class III · Terminated
Jan 13, 2020Sun Pharmaceutical Industries, Inc.
cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.		Class II · Terminated
Sep 26, 2019Arbor Pharmaceuticals Inc.
Labeling:Label Mix-up: Shipper Carton labelled Testosterone Cypionate Injection, USP, 200mg/mL, 1 ml single-dose vials, found to contain shelf cartons labelled as Testosterone Cypionate Injection USP, 200mg/mL, 10 ml multi-dose vials which contain Testosterone Cypionate Injection USP, 200mg/mL,1mL…		Class III · Terminated
Mar 21, 2019Invagen Pharmaceuticals, Inc.
Presence of Particulate Matter.		Class II · Terminated
Jul 11, 2018Sun Pharmaceutical Industries, Inc.
Presence of Particulate Matter: organic and inorganic compounds detected in vials of product.		Class II · Terminated
Mar 14, 2017Sun Pharmaceutical Industries, Inc.
Presence of Particulate Matter		Class II · Terminated

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Sources: CMS Medicare Part D Prescribers 2024; CMS Open Payments 2025 (general payments; a payment is not evidence of wrongdoing); FDA enforcement reports (openFDA).