The Recall Desk
CriticalFDA (Drugs)·D-1088-2015·Announced 2015-06-03

Strohecker's Pharmacy Recalls Testosterone Cypionate Vials Due to Incorrect Formulation

Strohecker's Pharmacy is recalling 365 vials of Testosterone Cypionate 200 mg/mL because they contain Estradiol Valerate 20 mg/mL instead.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

Strohecker's Pharmacy is recalling 365 vials of Testosterone Cypionate 200 mg/mL in Sesame Oil, 10 mL amber glass vials, Rx Only, Lot # T-1201S14, Exp 5/30/2015. The product was compounded by Strohecker's Pharmacy and distributed nationwide.

The recall was initiated because the vials are labeled as Testosterone Cypionate 200 mg/mL in Sesame Oil but actually contain Estradiol Valerate 20 mg/mL. This constitutes an incorrect product formulation.

Consumers who have this specific lot of product should stop using it and contact their healthcare provider or pharmacist for guidance on proper disposal or replacement.

The recalled product

Product
Testosterone Cypionate 200 mg/mL in Sesame oil, 10 mL amber glass vial, Rx Only, Lot# T-1201S14, Compounded by Strohecker's Pharmacy.
Affected units
365

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 (2)

  • Lot # T-1201S14
  • Exp 5/30/2015

Distribution

Distributed nationwide across the United States.