The Recall Desk
HighFDA (Drugs)·D-1237-2022·Announced 2022-07-20

FDA Recalls Compounded Testosterone Injection for Sterility Assurance

Tailor Made Compounding is recalling 93 vials of Testosterone Enanthate due to lack of assurance of sterility. The affected batches were distributed nationwide and in Puerto Rico.

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 involving lack of sterility assurance in an injectable medication, which is a risk-of-harm product. Per the rubric, a Class II recall without reported hospitalization or injury falls under High when the product poses a risk of harm but no illness has yet been reported.

Plain-English summary

Tailor Made Compounding has recalled Testosterone Enanthate (GSO) 100 mg/ml compounded injectable medication due to lack of assurance of sterility. The recall affects 93 vials from two batches: Batch 11102106A1 (expiration 4/30/2022) and Batch 01142230A1 (expiration 7/13/2022).

The medication was distributed nationwide throughout the United States and in Puerto Rico. The FDA has classified this as a Class II recall. Consumers or healthcare providers who have received this product should discontinue use and contact Tailor Made Compounding or their healthcare provider for information about disposal and next steps.

The recalled product

Product
Testosterone Enanthate (GSO) 100mg/ml, 2 mL-vial, Room temperature, Tailor Made Compounding
Manufacturer
TMC Acquisition LLC dba Tailor Made Compounding
Category
Drug — Compounded Injection
Hazard
  • sterility-failure

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 (4)

  • Batch#: 11102106A1
  • Exp 4/30/2022
  • 01142230A1
  • Exp 7/13/2022.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category