The Recall Desk
HighFDA (Drugs)·D-0234-2019·Announced 2018-11-14

Qualgen Recalls Testosterone Pellets Due to Sterility Concerns

Qualgen, LLC is recalling specific lots of Testosterone 25 mg pellets nationwide because the company lacks assurance of sterility for these products.

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: The recall is FDA Class II due to a lack of sterility assurance, which presents a risk of harm (infection) where injury has not yet been reported. This aligns with the High severity criteria for risk-of-harm products without reported illness.

Plain-English summary

Qualgen, LLC of Edmond, OK, has initiated a voluntary recall of Testosterone 25 mg pellets. The affected products include 1-count packages (NDC: 69761-125-01) and 30-count vials (NDC: 69761-125-30). The recall covers specific lots with expiration dates ranging from November 10, 2018, to March 23, 2019. Specifically, the recalled lots are C235, C241, C251, C265, D008, D018, D022, D032, D037, D057, D061, and D069.

The reason for the recall is a lack of assurance of sterility. This means the manufacturing process may not have guaranteed that the pellets are free from microorganisms, which poses a risk to patients using the drug.

The distribution of these products was nationwide. Consumers who possess any of the recalled lots should stop using them and contact their healthcare provider or pharmacist for guidance on disposal or replacement.

The recalled product

Product
Testosterone 25 mg pellet, 1 count (NDC: 69761-125-01) and 30 count vials (NDC: 69761-125-30), Rx Only Qualgen, LLC, Edmond, OK 73013
Manufacturer
Qualgen, LLC
Category
Drug — Testosterone Pellets
Hazard

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 (12)

  • Lots: C235 BUD: 11/10/2018
  • C241 BUD: 11/17/2018
  • C251 BUD: 12/8/2018
  • C265 BUD: 12/28/2018
  • D008 BUD: 1/9/2019
  • D018 BUD: 1/19/2019
  • D022 BUD: 1/25/2019
  • D032 BUD: 2/7/2019
  • D037 BUD: 2/13/2019
  • D057 BUD: 3/8/2019
  • D061 BUD: 3/14/2019
  • D069 BUD: 3/23/2019

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 14 recalled by Qualgen, LLC 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 14 products in this recall →

Related recalls

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Same hazard · lack of sterility

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