Testosterone Cypionate Injections Recalled for Sterility Assurance Failure
Tailor Made Compounding recalls Testosterone Cypionate injections due to lack of sterility assurance. The recall affects 4,219 vials distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall without reported illnesses or injuries in the source text. The hazard—lack of sterility assurance in an injectable drug—represents a risk-of-harm product where injury has not yet been reported. Per the severity rubric, this qualifies as High severity (Score 3).
Plain-English summary
Tailor Made Compounding is recalling Testosterone Cypionate 200mg/ml injectable solution in multiple vial sizes (2mL, 4mL, 5mL, and 10mL) due to a lack of assurance of sterility. The affected batches were distributed nationwide throughout the United States and Puerto Rico.
The recall was initiated because Tailor Made Compounding could not assure that the products met required sterility standards for injectable medications. This poses a potential risk to patients who receive these injections, as non-sterile products could introduce harmful bacteria or other microorganisms.
A total of 4,219 vials across multiple batch numbers and expiration dates are included in this recall. The affected batch numbers and expiration dates are listed in the FDA recall notice.
Patients who have received injections from the recalled batches should contact their healthcare provider. Healthcare providers should identify patients who may have received the recalled product and follow appropriate monitoring and treatment protocols if needed.
The recalled product
- 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
- Manufacturer
- TMC Acquisition LLC dba Tailor Made Compounding
- Category
- Drug
- Affected units
- 4,219
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Batch#: a)12212105A2
- Exp 6/19/2022
- 02182229A1
- Exp 8/17/2022
- b) 12012121A2
- Exp 5/30/2022
- 12212104A2
- 01242216A2
- Exp 7/23/2022
- 02182236A1
- c) 12072133A1
- Exp 6/5/2022
- 01192225A1
- Exp 7/18/2022
- 02182228A1
- d)10142105A
- Exp 4/12/2022
- 10272105A1
- Exp 4/25/2022
- 11102101A1
Distribution
Part of a larger recall action
This product is one of 52 recalled by TMC Acquisition LLC dba Tailor Made Compounding under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 52 products in this recall →Related recalls
Same manufacturer · TMC Acquisition LLC dba Tailor Made Compounding
See all →- HighDexpanthenol Preservative Free Injectable Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2022-07-20
- HighHydroxocobalamin Compounded Injections Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-07-20
- HighTailor Made Compounding Recalls Glycyrrhizic Acid Injectable for Lack of Sterility Assurance
FDA (Drugs) · 2022-07-20
- HighFDA Recalls Tailor Made Compounding GAC Injectable Vials for Lack of Sterility Assurance
FDA (Drugs) · 2022-07-20
- HighEstradiol Cypionate Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-07-20
Same hazard · sterility assurance
See all →- HighArrowhead DE LLC Recalls Arrow-LOK Implants Due to Sterility Assurance Concerns
FDA (Devices) · 2026-08-26
- SevereChloraPrep One-Step Applicators Recalled for Potential Packaging Seal Defects
FDA (Drugs) · 2026-07-22
- SeverePemetrexed for Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15
- SevereChloraPrep One-Step Applicators Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2026-07-08
- SevereArrow access trays and PSI kits contain recalled supplier drugs
FDA (Devices) · 2026-06-24