RecallRadar

FDA Drug recall D-1231-2022

Testosterone Cypionate (GSO) 200mg/ml a) 2 mL-vial, b) 4 mL-vial, c) 5 mL-vial, d) 10 mL-vial, Room temperature, Tailor Made Compounding

On 2022-07-20 the FDA classified a Class II recall of Testosterone Cypionate (GSO) 200mg/ml a) 2 mL-vial, b) 4 mL-vial, c) 5 mL-vial, d) 10 mL-vial, Room temperature, Tailor Made Compounding by Tmc Acquisition, citing lack of Assurance of Sterility.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1231-2022
ClassificationClass II
Statusongoing
Initiated2022-03-07
Published2022-07-20
Last updated2026-09-13 11:52 UTC
CompanyTmc Acquisition
DistributionUS

Product

Testosterone Cypionate (GSO) 200mg/ml a) 2 mL-vial, b) 4 mL-vial, c) 5 mL-vial, d) 10 mL-vial, Room temperature, Tailor Made Compounding

Reason

Lack of Assurance of Sterility

Identifiers

code_info
Batch#: a)12212105A2, Exp 6/19/2022; 02182229A1, Exp 8/17/2022; b) 12012121A2, Exp 5/30/2022; 12212104A2, Exp 6/19/2022…Batch#: a)12212105A2, Exp 6/19/2022; 02182229A1, Exp 8/17/2022; b) 12012121A2, Exp 5/30/2022; 12212104A2, Exp 6/19/2022; 01242216A2, Exp 7/23/2022; 02182236A1, Exp 8/17/2022; c) 12072133A1, Exp 6/5/2022; 01192225A1, Exp 7/18/2022; 02182228A1, Exp 8/17/2022; d)10142105A, Exp 4/12/2022; 10272105A1, Exp 4/25/2022; 11102101A1, 11032120A2, Exp 4/30/2022; 11222116A2, Exp 5/21/2022; 12012121A2, Exp 5/30/2022; 12072132A1, Exp 6/5/2022; 12152110A1, Exp 6/13/2022; 12162118A1, Exp 6/14/2022; 12212103A2, Exp 6/19/2022; 01052206A1, Exp 7/4/2022; 01142229A1, Exp 7/13/2022; 01212207A2 Exp, 7/20/2022; 02042201A1, Exp 8/3/2022; 02182226A1, Exp 8/17/2022; 02252224A1, 02252226A1, Exp 8/24/2022.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1231-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.