The Recall Desk
HighFDA (Drugs)·D-1235-2022·Announced 2022-07-20

Testosterone Injections Recalled for Lack of Sterility Assurance

Tailor Made Compounding is recalling 246 vials of compounded testosterone injections distributed nationwide due to lack of assurance of sterility. Non-sterile injectable medications may pose a risk of infection.

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 a risk-of-harm product (injectable medication) where lack of sterility assurance could lead to serious infections. No illnesses or injuries have been reported in the source material, placing it at the high-risk but non-severe threshold.

Plain-English summary

Tailor Made Compounding has initiated a recall of compounded testosterone injections (testosterone cypionate/enanthate/propionate 80/80/40mg) in both 5 mL and 10 mL vials due to lack of assurance of sterility. The recall affects 246 vials distributed nationwide, including Puerto Rico, across seven batches with expiration dates ranging from April to August 2022.

The lack of assurance of sterility means the products may not have been produced under proper conditions to ensure they are free from harmful microorganisms. Non-sterile injectable medications pose a risk of serious infections when injected.

Patients who have received these injections should contact their healthcare provider. Healthcare providers and patients should verify batch numbers (10202107A1, 10142120A2, 10272102A1, 11032117A2, 11102104A2, 01252212A2, 02182227A1) against the product they have. Any vials matching these batch numbers should not be used.

The recalled product

Product
Testosterone Cypionate/Enanthate/Propionate 80/80/40mg, a) 5 mL-vial, b) 10 ml-vial, Room temperature, Tailor Made Compounding
Manufacturer
TMC Acquisition LLC dba Tailor Made Compounding
Category
Drug — Injectable / Hormone Therapy
Hazard
  • lack-of-sterility
  • contamination-risk

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 (13)

  • Batch#: a) 10202107A1
  • Exp 4/18/2022
  • b) 10142120A2
  • Exp 4/12/2022
  • 10272102A1
  • Exp 4/25/2022
  • 11032117A2
  • 11102104A2
  • Exp 4/30/2022
  • 01252212A2
  • Exp 7/24/2022
  • 02182227A1
  • Exp 8/17/2022 .

Distribution

Distributed nationwide across the United States.

Related recalls

Same category