Agency classClass IIOur severity:High FDA (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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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
Affected units: 93

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.

The notice also names 1 state specifically:

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 →

Same manufacturer · TMC Acquisition LLC dba Tailor Made Compounding

See all →

High
Dexpanthenol Preservative Free Injectable Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2022-07-20
High
Hydroxocobalamin Compounded Injections Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-07-20
High
Tailor Made Compounding Recalls Glycyrrhizic Acid Injectable for Lack of Sterility Assurance
FDA (Drugs) · 2022-07-20
High
FDA Recalls Tailor Made Compounding GAC Injectable Vials for Lack of Sterility Assurance
FDA (Drugs) · 2022-07-20
High
Estradiol Cypionate Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-07-20

Same hazard · sterility failure