The Recall Desk
HighFDA (Drugs)·D-0735-2022·Announced 2022-04-06

Testosterone Cypionate Injectable Recalled for Lack of Sterility Assurance

Drug Depot recalled 17 vials of Testosterone Cypionate Injectable due to lack of sterility assurance in manufacturing. The recalled product was distributed nationwide and should not be used.

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. The hazard—lack of sterility assurance in an injectable medication—represents a significant risk of infection. No illnesses or injuries have been reported. Per the rubric, this qualifies as a high-risk, risk-of-harm product where injury has not yet been reported.

Plain-English summary

Drug Depot, Inc. (operating as APS Pharmacy) has recalled Testosterone Cypionate Injectable, 80 mg/mL, supplied in multi-dose 10mL vials. The recall affects 17 vials of Lot 746269 with a Beyond Use Date of June 27, 2022.

The product is being recalled due to lack of sterility assurance in the manufacturing process. Non-sterile injectables pose a risk of serious infection to patients receiving injections.

The recalled product was distributed nationwide in the United States, including Puerto Rico. Patients and healthcare providers who have this product should not use it and should contact their pharmacy or healthcare provider for guidance on disposal and any necessary medical evaluation.

The recalled product

Product
TESTOSTERONE CYPIONATE *GS* (2 mL) 80 MG/ML Injectable, Packaged in a multi dose 10ML vial, Formula ID 127492, APS Pharmacy
Manufacturer
Drug Depot, Inc., dba APS Pharmacy
Hazard
  • lack-of-sterility
  • infection-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 (1)

  • Lot: 746269 BUD: 6/27/2022

Distribution

Distributed nationwide across the United States.