The Recall Desk
HighFDA (Drugs)·D-1231-2022·Announced 2022-07-20

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
Hazard
  • sterility-assurance
  • 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 (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

Distributed nationwide across the United States.

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